Capivasertib (Truqap) in 2026
Capivasertib — sold under the brand name Truqap and developed by AstraZeneca — has emerged as one of the most clinically significant oncology drugs of the 2020s, earning its place as the world’s first and only FDA-approved AKT inhibitor. Since its landmark US approval on November 16, 2023, for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer harboring one or more PIK3CA/AKT1/PTEN alterations, capivasertib has reshaped treatment strategy for up to half of all patients in its eligible population — a demographic defined by alterations in the PI3K/AKT pathway, the most commonly mutated signaling cascade in all of human cancer. By 2025, the drug had generated $728 million in annual revenue, a staggering 68–69% year-over-year increase from 2024, making it one of the fastest-growing oncology launches in AstraZeneca’s recent history and signaling that real-world adoption of precision AKT targeting had firmly taken hold in clinical practice.
The year 2026 brought capivasertib to an entirely new frontier. On April 30, 2026, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7 to 1, with 1 abstention, in recognition of a favorable benefit-risk profile for capivasertib in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC) — based on the pivotal Phase III CAPItello-281 trial. If approved by the FDA — which is not bound by ODAC’s recommendation but typically follows it — capivasertib would become the first targeted therapy ever approved for PTEN-deficient mHSPC, a biomarker-defined population representing roughly 25% of all mHSPC patients, or approximately 9,750 patients per year in the US alone. That vote, combined with a full pipeline of ongoing Phase III programs, a Q4 2025 quarterly revenue of $233 million, and parallel EU regulatory reviews, establishes 2026 as the year capivasertib’s story expands far beyond its original breast cancer beachhead.
Interesting Key Facts About Capivasertib in 2026
CAPIVASERTIB (TRUQAP) — FAST FACTS SNAPSHOT (2026)
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Brand Name TRUQAP® (AstraZeneca)
Drug Class First-in-class AKT inhibitor (AKT1/AKT2/AKT3)
US FDA Approval November 16, 2023 (Breast Cancer)
EU Approval June 2024 (Breast Cancer)
FDA ODAC Vote (2026) April 30, 2026 — 7-1-1 ✓ FAVORABLE (Prostate Cancer)
2025 Full-Year Revenue ██████████████████████████████████ $728 Million (+68–69% YoY)
Q4 2025 Revenue ████████████████████████ $233 Million (+43% YoY)
Breast Cancer PFS Gain ████████████████████ 7.3 mo vs 3.1 mo (PIK3CA+ pop.)
Prostate Cancer rPFS ████████████████████████████ 33.2 mo vs 25.7 mo (CAPItello-281)
Eligible US Patients Breast (AKT-altered): ~50% of HR+/HER2- patients
Eligible US Patients Prostate (PTEN-deficient mHSPC): ~9,750/year
Peak Sales Estimate ██████████████████████████ $1.28B (Leerink, post-restriction)
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| Fact | Detail |
|---|---|
| Brand Name | TRUQAP® |
| Generic Name | Capivasertib (also known as AZD5363) |
| Developer / Manufacturer | AstraZeneca (originated via collaboration with Astex Therapeutics and the Institute of Cancer Research) |
| Drug Class | First-in-class, first-and-only FDA-approved AKT inhibitor — potent ATP-competitive pan-AKT kinase inhibitor |
| AKT Isoforms Inhibited | All three: AKT1, AKT2, and AKT3 |
| Mechanism of Action | Blocks the PI3K/AKT signaling pathway — the most commonly altered signaling pathway in human cancers |
| PI3K/AKT pathway alteration rate (all cancers) | ~38% of cancer patients have PI3K/AKT pathway alterations (PIK3CA 13%, PTEN 30%, AKT1 1%) |
| PI3K/AKT pathway in breast cancer | Over 50% of breast tumors harbor alterations (PIK3CA 31%, PTEN 34%, PTEN mutations 5%, AKT1 3%) |
| US FDA Approval (Breast Cancer) | November 16, 2023 — approved with fulvestrant for HR+/HER2- metastatic breast cancer with PIK3CA/AKT1/PTEN alteration(s) |
| EU Approval (Breast Cancer) | June 2024 — European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion |
| FDA Priority Review / Fast Track | Received both Priority Review designation and Fast Track designation from FDA |
| Companion Diagnostic (US) | FoundationOne® CDx assay — approved simultaneously as companion diagnostic to identify eligible patients |
| Dosing Schedule | 400 mg orally twice daily, 4 days on / 3 days off, per 28-day treatment cycle |
| FDA ODAC Vote (Prostate Cancer) | April 30, 2026 — voted 7 to 1, with 1 abstention, favorable benefit-risk profile for PTEN-deficient mHSPC |
| 2025 Full-Year Revenue | $728 million (+68–69% vs 2024) |
| Q4 2025 Revenue | $233 million (+43% vs Q4 2024) |
| AZ Oncology Q4 2025 Total Revenue | $7.03 billion (+22% year-over-year) |
| AZ Licensing Cost (from Astex, 2005) | $5 million upfront + $270 million in milestone payments |
| Leerink Peak Sales Estimate | $1.28 billion (revised downward from $2.36B after biomarker restriction in 2023) |
| GlobalData Consensus Sales Forecast | $662 million in 2029 (pre-prostate cancer indication) |
| Patent Expiry | 2030 |
Source: FDA.gov (Nov 2023), AstraZeneca-US.com press releases (2026), AstraZeneca SEC Form 6-K FY2025 & FY2026, Precision Medicine Online (Feb 2026), Pharmaphorum (Feb 2026), Fierce Pharma (Nov 2023), PMC / NCBI Capivasertib review, CancerNetwork, OncLive
The facts table above makes one thing unmistakably clear: capivasertib’s revenue trajectory in 2025 was extraordinary by any pharmaceutical benchmark. A 68–69% year-over-year revenue jump — from approximately $430 million in 2024 to $728 million in 2025 — is the kind of growth that defines a launch-phase blockbuster rather than a mature drug in steady-state commercial decline. The Q4 2025 quarterly figure of $233 million alone exceeds the GlobalData consensus forecast of $662 million for the full year 2029, suggesting that real-world adoption has substantially outpaced initial analyst models. That acceleration reflects not just strong uptake in the approved breast cancer indication but growing physician familiarity with biomarker-driven AKT pathway targeting as a distinct therapeutic logic, complementing the CDK4/6 inhibitor-plus-endocrine backbone that defines first-line treatment in HR+/HER2- advanced breast cancer.
The $1.28 billion revised peak sales estimate from Leerink — already reflecting the downward adjustment from $2.36 billion following the FDA’s narrower-than-expected biomarker-restricted breast cancer label — is now looking conservative in light of the April 30, 2026 ODAC favorable vote for prostate cancer. If the FDA follows the committee’s recommendation and approves the supplemental NDA for PTEN-deficient mHSPC, a market of approximately 9,750 eligible US patients per year would be added to capivasertib’s commercial addressable population, materially revising every peak-revenue estimate currently in circulation. AstraZeneca CEO Pascal Soriot’s stated goal of having more than 25 blockbuster brands (>$1 billion annual sales) by 2030 places Truqap squarely on the list of drugs expected to cross that threshold — a milestone that now appears achievable within the drug’s remaining patent exclusivity window before 2030.
Capivasertib FDA Approval & ODAC Vote Statistics in the US 2026
CAPIVASERTIB FDA REGULATORY MILESTONES — FULL TIMELINE
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2005 AZ licenses capivasertib from Astex Therapeutics ($5M upfront + $270M milestones)
2021 Phase III CAPItello-291 trial (NCT04305496) enrolls 708 patients — breast cancer
Nov 2023 FDA APPROVES capivasertib + fulvestrant — HR+/HER2- mBC (PIK3CA/AKT1/PTEN+)
Nov 2023 FoundationOne CDx approved simultaneously as companion diagnostic
Jun 2024 EU (EMA) APPROVES capivasertib + fulvestrant — breast cancer indication
Aug 2025 FDA accepts sNDA for capivasertib + abiraterone + ADT (prostate cancer)
2025 CAPItello-281 results presented at ESMO 2025 + published in Annals of Oncology
Apr 2026 ASCO GU 2026 — CAPItello-281 efficacy data presented
Apr 30, 2026 FDA ODAC VOTES 7-1-1 favorable — PTEN-deficient mHSPC (prostate cancer)
Pending FDA formal decision on sNDA for prostate cancer indication
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| Regulatory Milestone | Date | Detail |
|---|---|---|
| US FDA Approval — Breast Cancer | November 16, 2023 | Approved 2 weeks ahead of FDA goal date; Priority Review + Fast Track designations granted |
| Approved Breast Cancer Indication | Nov 2023 | HR+/HER2– locally advanced or metastatic BC with ≥1 PIK3CA/AKT1/PTEN alteration; post ≥1 endocrine regimen in metastatic setting or recurrence ≤12 months after adjuvant therapy |
| Companion Diagnostic (US) | Nov 16, 2023 | FoundationOne® CDx — only FDA-approved test to identify eligible BC patients for Truqap |
| FDA Project Orbis | Nov 2023 | Reviewed under Project Orbis — concurrent review with Australia, Brazil, Canada, Israel, Singapore, Switzerland, UK |
| EU (EMA) Approval — Breast Cancer | June 2024 | CHMP positive opinion; approved for ER+/HER2– locally advanced or metastatic BC with PIK3CA/AKT1/PTEN alterations |
| FDA sNDA Acceptance — Prostate Cancer | August 2025 | sNDA accepted for Truqap + abiraterone + ADT for PTEN-deficient mHSPC; based on CAPItello-281 |
| CAPItello-281 Publication | 2025/2026 | Phase III results published in Annals of Oncology (2026;37(1):53–68) and presented at ESMO 2025 |
| ASCO GU 2026 Data Presentation | Early 2026 | CAPItello-281 patient-reported outcomes and rPFS data presented (J Clin Oncol. 2026;44[suppl 7]:14) |
| FDA ODAC Vote — Prostate Cancer | April 30, 2026 | ODAC voted 7 to 1, with 1 abstention — favorable benefit-risk for Truqap + abiraterone + ADT in PTEN-deficient mHSPC |
| ODAC Vote Characterization | Apr 2026 | AstraZeneca: “overwhelming majority” — first and only targeted treatment combination to demonstrate benefit in this subtype |
| EU Regulatory Review — Prostate Cancer | Ongoing (2026) | Parallel EU regulatory application under review based on CAPItello-281 |
| CAPItello-280 (mCRPC) — Discontinued | April 2025 | Phase III trial in metastatic castration-resistant prostate cancer discontinued; IDMC recommended discontinuation — unlikely to meet dual primary endpoints of rPFS and OS |
| FDA Formal Decision — Prostate Cancer | Pending | FDA is not bound by ODAC vote; formal approval decision expected in 2026 |
Source: FDA.gov, AstraZeneca-US.com (press releases 2023–2026), AstraZeneca SEC Form 6-K FY2026, OncLive (April 30, 2026), CancerNetwork (April 30, 2026), Urology Times (April 30, 2026), Annals of Oncology
The April 30, 2026 ODAC vote of 7-1-1 is the most consequential regulatory event in capivasertib’s 2026 story — and almost certainly its most watched. ODAC meetings had been on a nine-month hiatus before this session, meaning the committee was operating in a post-Pazdur FDA environment that analysts had flagged as applying heightened scrutiny to biomarker-defined subgroup data. The fact that the committee voted so decisively in favor — with only a single dissent and one abstention — reflects the clarity of the CAPItello-281 benefit-risk case in the PTEN-deficient mHSPC subgroup: a 19% reduction in the risk of radiographic progression or death, a 7.5-month gain in median rPFS (33.2 vs. 25.7 months), and numerically favorable interim overall survival data. The committee member who framed his “yes” vote around “clinical meaningfulness” and real-world deployment context — Dr. Neil Vasan of NYU Grossman School of Medicine — captured the spirit of the majority: this is a targeted therapy filling a genuine unmet need in a biomarker-selected population that currently has no precision treatment option.
The discontinuation of CAPItello-280 in April 2025 — AstraZeneca’s trial of capivasertib in metastatic castration-resistant prostate cancer — provides important context for interpreting the CAPItello-281 success. The IDMC’s conclusion that CAPItello-280 was “unlikely to meet its dual primary endpoints” in the mCRPC setting underscores that capivasertib’s biological activity is not a blanket prostate cancer story: it is specifically tied to the PI3K/AKT pathway activation present in PTEN-deficient tumors in the hormone-sensitive setting, where endocrine signaling and AKT signaling interact reciprocally in a way that makes combined inhibition particularly effective. AstraZeneca’s own scientists explicitly cited this endocrine–AKT reciprocal relationship as the mechanistic logic connecting the breast cancer approval to the prostate cancer opportunity — a point that will likely feature prominently in the FDA’s formal review of the prostate cancer sNDA.
Capivasertib Breast Cancer Clinical Trial Statistics in the US 2026
CAPItello-291 TRIAL — PROGRESSION-FREE SURVIVAL RESULTS
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Population Capivasertib + Fulvestrant Placebo + Fulvestrant HR
Overall (n=708) 7.2 months ████████████ 3.6 months ████ 0.60 (p<0.001)
AKT-altered (n=289) 7.3 months ████████████ 3.1 months ███ 0.50 (p<0.0001)
AKT non-altered ~Same benefit (~HR 0.79 — not statistically significant)
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Capivasertib + fulvestrant cut risk of progression/death by 50% in AKT-altered patients
| CAPItello-291 Trial Metric | Capivasertib + Fulvestrant | Placebo + Fulvestrant | Statistical Result |
|---|---|---|---|
| Trial Design | Randomized, double-blind, placebo-controlled, multicenter Phase III | — | NCT04305496 |
| Total Patients Enrolled | 708 patients (HR+/HER2– locally advanced or metastatic BC) | — | 1:1 randomization |
| Patients with PIK3CA/AKT1/PTEN alteration | 289 patients (biomarker-positive population) | — | ~41% of total |
| Patients without alteration (exploratory) | 313 patients | — | ~44% of total |
| Median PFS — Overall Population | 7.2 months (95% CI: 5.5–7.4) | 3.6 months (95% CI: 2.8–3.7) | HR 0.60; p < 0.001 |
| Median PFS — AKT-Altered Population | 7.3 months (95% CI: 5.5–9.0) | 3.1 months (95% CI: 2.0–3.7) | HR 0.50; p < 0.0001 — 50% risk reduction |
| Median PFS — AKT Non-altered (exploratory) | Numerical but not statistically significant benefit | — | HR 0.79 (95% CI: 0.61–1.02) |
| Interim OS — AKT-Altered Group | Risk of death reduced by 31% | — | Interim analysis; follow-up ongoing |
| Interim OS — Overall Population | Risk of death reduced by 26% | — | Interim analysis; follow-up ongoing |
| CDK4/6 Inhibitor Prior Therapy | 69.1% of all enrolled patients had received prior CDK4/6 inhibitor | — | Key treatment context |
| Discontinuation Rate (Capivasertib) | 82.3% discontinued capivasertib | 87.7% discontinued | Main reason: disease progression |
| Key Adverse Events | Diarrhea (72% all-grade, 9% Grade ≥3); cutaneous reactions (58% all-grade, 17% Grade ≥3); hyperglycemia (18% all-grade, 2.8% Grade ≥3) | — | Grade ≥3 toxicities higher with capivasertib |
| Patients Still on Treatment at Cutoff | 17.7% still receiving therapy | — | Durability signal |
Source: FDA.gov approval summary (Nov 16, 2023), OncLive (Nov 2023), CancerNetwork (Nov 2023), PubMed / FDA Approval Summary (PMID: 39159418), AstraZeneca-US official
The CAPItello-291 data set remains the clinical foundation upon which all of capivasertib’s commercial and regulatory success rests, and the numbers hold up under close examination. The 50% reduction in the risk of disease progression or death in the AKT-altered population (HR 0.50) is among the most compelling hazard ratios reported in post-CDK4/6 inhibitor breast cancer therapy — a treatment setting where new options are desperately needed and where median PFS of 3.6 months on standard fulvestrant alone tells you exactly how poorly patients in this heavily pretreated line have historically fared. The fact that 69.1% of trial participants had already received a CDK4/6 inhibitor — the current standard first-line backbone — makes the PFS results even more clinically meaningful: capivasertib is delivering that benefit in a population whose disease has already developed resistance to the most effective treatment currently available for their cancer type.
The FDA’s decision to restrict the label to the AKT-altered population only — rather than all HR+/HER2– patients, as AstraZeneca had hoped — reflected the non-significant exploratory PFS result in the non-altered population (HR 0.79, CI: 0.61–1.02), combined with the drug’s meaningful toxicity burden including grade ≥3 cutaneous reactions in 17% of patients and grade ≥3 diarrhea in 9%. That restriction, while commercially constraining, is scientifically defensible: the entire premise of precision oncology is that biomarker-selected populations respond more robustly to pathway-targeted agents, and capivasertib’s own trial data confirmed exactly that hierarchy. With over 50% of HR+/HER2– breast cancer patients harboring PIK3CA/AKT1/PTEN alterations in their tumors, the addressable market remains substantial even within the restricted label — a biological reality that made the FoundationOne CDx companion diagnostic not just a regulatory requirement but a genuine market-expansion tool.
Capivasertib Prostate Cancer ODAC Vote Statistics in the US 2026
CAPItello-281 TRIAL — PROSTATE CANCER EFFICACY RESULTS (ODAC Apr 30, 2026)
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Endpoint Capivasertib + Abi + ADT Placebo + Abi + ADT Result
rPFS (primary) 33.2 months ████████████ 25.7 months ████████ HR 0.81 p=.034
Time to castration-R 29.5 months ██████████ 22.0 months ████████ HR 0.77
PSA progression — ██████████ — ████████ HR 0.73
SSE-free survival 42.5 months ████████████ 37.3 months ██████████ HR 0.82
OS (immature) — ████████████ — ████████ HR 0.90 (n.s.)
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ODAC VOTE: 7 YES — 1 NO — 1 ABSTAIN ✓ FAVORABLE BENEFIT-RISK
| CAPItello-281 Trial Metric | Capivasertib + Abi + ADT | Placebo + Abi + ADT | Statistical Result |
|---|---|---|---|
| Trial Design | Phase III, double-blind, randomized (1:1) | — | NCT04493853; de novo mHSPC, ECOG 0–1 |
| Total Patients Enrolled | 1,012 patients with PTEN-deficient de novo hormone-sensitive prostate adenocarcinoma | — | PTEN deficiency confirmed by central testing |
| PTEN Testing Method | VENTANA PTEN (SP218) IHC assay — prospective, central testing | — | Biomarker-first trial design |
| PTEN Deficiency Prevalence in mHSPC | ~25% of all mHSPC cases | — | ~9,750 eligible US patients/year |
| Capivasertib Dosing | 400 mg BID, 4 days on / 3 days off + abiraterone 1000 mg QD + prednisone/prednisolone + ADT | — | Same intermittent schedule as breast cancer approval |
| Primary Endpoint — rPFS | 33.2 months (95% CI: 25.8–44.2) | 25.7 months (95% CI: 22.0–29.9) | HR 0.81; p = 0.034 — 19% risk reduction in radiographic progression or death |
| rPFS gain (months) | +7.5 months median improvement | — | Primary endpoint met |
| Time to Castration Resistance | 29.5 months | 22.0 months | HR 0.77 (95% CI: 0.63–0.94) |
| PSA Progression | Fewer PSA progression events | — | HR 0.73 (95% CI: 0.52–1.01) |
| Symptomatic Skeletal Event-Free Survival | 42.5 months | 37.3 months | HR 0.82 (95% CI: 0.66–1.02) |
| Overall Survival (OS) | Numerically favors capivasertib | — | HR 0.90; p = 0.401 — immature data; trial continuing |
| Grade ≥3 Adverse Events | 67.0% | 40.4% | Substantially higher toxicity burden |
| Serious Adverse Events (SAEs) | 42.5% | 26.0% | Higher SAE rate in capivasertib arm |
| Discontinuation due to AEs | 18% | 5% | Management-intensive safety profile |
| ODAC Vote — April 30, 2026 | 7 YES / 1 NO / 1 ABSTAIN | — | Favorable benefit-risk profile recognized |
| If Approved: First-Ever Targeted Therapy for This Population? | YES — first and only targeted treatment combination for PTEN-deficient mHSPC | — | Significant unmet need addressed |
Source: AstraZeneca SEC Form 6-K FY2026, AstraZeneca-US.com ODAC press release (April 2026), OncLive (April 30, 2026), CancerNetwork (April 30, 2026), Urology Times (April 30, 2026), Targeted Oncology (April 30, 2026), Annals of Oncology 2026;37(1):53-68
The CAPItello-281 data told a nuanced story that ODAC debated carefully before its 7-1-1 favorable vote. The primary endpoint was met: median radiographic PFS improved by a clinically meaningful 7.5 months — a result that was consistent across most subgroups, independent of disease risk stratification and metastatic tumor volume, and strengthened further in patients with the highest degree of PTEN deficiency (100% PTEN-deficient subgroup showed numerically greater benefit). The secondary endpoints — time to castration resistance (HR 0.77), PSA progression (HR 0.73), and symptomatic skeletal event-free survival (HR 0.82) — all pointed in the same direction, creating a coherent benefit narrative across multiple clinically relevant outcome measures. The immature overall survival hazard ratio of 0.90 was not statistically significant, but as ODAC members acknowledged, OS immaturity at interim analysis is expected for a de novo mHSPC population with relatively long survival times.
The single dissenting vote and the regulatory debate centered primarily on the toxicity profile: grade ≥3 adverse events in 67.0% of capivasertib-treated patients versus 40.4% in the placebo arm, a 42.5% vs. 26.0% serious adverse event rate, and a discontinuation rate of 18% versus 5% paint a picture of a management-intensive regimen. ODAC scrutiny was particularly intense because the target population — patients with de novo mHSPC, many of whom are asymptomatic at diagnosis — are being asked to accept a substantial toxicity burden in exchange for a 7.5-month rPFS benefit on top of an already effective abiraterone-ADT backbone. The committee member who abstained cited this tension directly. That said, the 7-to-1 majority conclusion was that the totality of evidence — including the high-risk biology of PTEN-deficient prostate cancer, the inevitable and rapid progression to castration-resistant disease in this subgroup, and the lack of any existing targeted option — justified a favorable benefit-risk determination.
Capivasertib Revenue & Commercial Statistics in 2026
TRUQAP (CAPIVASERTIB) REVENUE GROWTH TRAJECTORY
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2024 Annual Revenue ████████████████████ ~$430M (est., basis for 68% growth)
2025 Annual Revenue ████████████████████████████████████ $728M (+68–69% YoY)
Q4 2025 Revenue ████████████████████████ $233M (+43% YoY)
Leerink Peak Estimate ████████████████████████████████████████████████ $1.28B
GlobalData 2029 Est. ████████████████████████████████████ $662M (pre-prostate cxn.)
AZ Oncology Q4 2025 ████████████████████████████████████████████████████████████████ $7.03B (total)
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Note: AZ Truqap revenues include US + global; prior $430M estimate calculated from 69% growth to $728M
| Revenue / Commercial Metric | Figure | Period / Source |
|---|---|---|
| Truqap Full-Year Revenue (2025) | $728 million | FY2025 — AstraZeneca SEC Form 6-K, Feb 2026 |
| Truqap Year-over-Year Revenue Growth (2025) | +68–69% | vs. 2024 full-year |
| Truqap Q4 2025 Revenue | $233 million | Q4 2025 (Oct–Dec) |
| Truqap Q4 2025 YoY Revenue Growth | +43% | vs. Q4 2024 |
| Truqap Q2 2024 Revenue | $92 million | Q2 2024 — AstraZeneca Q2 earnings |
| AstraZeneca Oncology Total Revenue (Q4 2025) | $7.03 billion | Q4 2025 (+22% YoY) |
| Truqap as % of AZ Oncology Q4 2025 | ~3.3% of total AZ oncology revenue | Calculated |
| Leerink Peak Sales Estimate | $1.28 billion (reduced from $2.36B after biomarker restriction) | Leerink post-approval analysis, Nov 2023 |
| GlobalData Consensus Forecast | $662 million in 2029 | GlobalData (pre-prostate cancer indication data) |
| AZ Oncology Goal (2030) | 25+ blockbuster brands (>$1B annual revenue each) — Truqap on target list | AstraZeneca CEO Pascal Soriot, Feb 2026 |
| US Market Position | Only FDA-approved AKT inhibitor — no direct approved competitor | DelveInsight AKT Inhibitor Market (2025) |
| Key Competitive Threat (Breast Cancer) | Novartis Piqray (alpelisib) — PIK3CA-specific inhibitor; different pathway node | Fierce Pharma |
| AstraZeneca Original Licensing Cost | $5M upfront + $270M milestones (paid to Astex Therapeutics, 2005) | Fierce Pharma / ClinicalTrialsArena |
| Return on Licensing Investment | $728M revenue in 2025 alone vs. ~$275M total licensing cost | Calculated |
Source: AstraZeneca SEC Form 6-K FY2025 (filed Feb 2026), Precision Medicine Online (Feb 2026), Pharmaphorum (Feb 2026), Fierce Pharma (Nov 2023), GlobalData / ClinicalTrialsArena (Nov 2023), DelveInsight AKT Inhibitor Market Report
The return on AstraZeneca’s investment in capivasertib is a case study in long-cycle pharmaceutical development paying off exponentially. The $275 million total licensing cost paid to Astex Therapeutics in 2005 — when capivasertib was still a preclinical compound with no human data — generated $728 million in a single calendar year by 2025, nearly 2.6 times the entire investment in one year. That arc — from a $5 million upfront payment to a drug on track for blockbuster status — reflects both the scientific risk-tolerance that AstraZeneca has historically applied to its oncology pipeline and the clinical insight that AKT pathway inhibition, despite multiple earlier failures across the industry, was a mechanistically sound strategy in biomarker-selected populations. The FoundationOne CDx companion diagnostic co-approval was a crucial commercial enabler: it created a standardized, FDA-cleared pathway for biomarker testing that drove physician confidence and ensured that eligible patients could actually be identified at the point of prescribing decision.
The competitive moat capivasertib currently enjoys is structurally unusual: as the world’s first and only FDA-approved AKT inhibitor, it occupies a therapeutic niche with no direct approved competitor. Novartis’ Piqray (alpelisib) targets PIK3CA specifically — an upstream node in the same pathway — but covers only the PIK3CA-mutated subset, while capivasertib’s pan-AKT inhibition covers PIK3CA mutations, AKT1 mutations, AND PTEN loss simultaneously. Multiple companies (including Almac Discovery with ALM301 and others in Phase I/II) are developing next-generation AKT inhibitors, but none have advanced to Phase III approval candidacy, meaning capivasertib is likely to maintain its first-mover advantage through its 2030 patent expiry — and potentially beyond, if the prostate cancer indication drives the label expansion that AstraZeneca’s executives have repeatedly telegraphed as the company’s strategic intent.
Capivasertib Global Breast Cancer Epidemiology Statistics in 2026
BREAST CANCER & AKT PATHWAY — TARGET PATIENT POPULATION (2026)
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All new BC cases (US, est. 2026) ██████████████████████ ~310,000
HR+/HER2– BC share of all BC ████████████████████████ ~70%
HR+/HER2– with AKT pathway alteration ████████████████████████ ~50% of HR+/HER2–
PIK3CA mutations in breast cancer ████████████████ 31%
PTEN loss in breast cancer ████████████████████ 34%
PTEN mutations in breast cancer ████ 5%
AKT1 mutations in breast cancer ██ 3%
PI3K/AKT pathway (all cancers) ████████████████████████ 38% of all cancer patients
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| Epidemiology / Patient Population Metric | Statistic | Source |
|---|---|---|
| Global breast cancer new cases annually | ~2.3 million per year | WHO / Global Cancer Observatory |
| HR+/HER2– breast cancer share | ~70% of all breast cancer cases | Standard oncology literature |
| HR+/HER2– patients with AKT pathway alteration | ~50% — up to half of all HR+/HER2– patients | AstraZeneca / CAPItello-291 eligibility data |
| PIK3CA mutation rate in breast cancer | 31% | PMC Capivasertib review (2022) |
| PTEN loss in breast cancer | 34% | PMC Capivasertib review (2022) |
| PTEN mutations in breast cancer | 5% | PMC Capivasertib review (2022) |
| AKT1 mutations in breast cancer | 3% | PMC Capivasertib review (2022) |
| PI3K/AKT pathway alteration — all cancers | ~38% of cancer patients (PIK3CA 13%, PTEN 30%, AKT1 1%) | PMC / NCBI |
| CAPItello-291 prior CDK4/6 inhibitor use | 69.1% of trial patients had received prior CDK4/6 inhibitor | FDA / CancerNetwork |
| PTEN deficiency in mHSPC (prostate) | ~25% of all metastatic hormone-sensitive prostate cancer cases | Targeted Oncology / AstraZeneca, April 2026 |
| PTEN-deficient mHSPC eligible patients (US/year) | ~9,750 patients/year | Targeted Oncology / AstraZeneca sNDA briefing, April 2026 |
| US prostate cancer new cases (mHSPC context) | De novo mHSPC: a significant subset of ~36,000 estimated new metastatic prostate cancer cases/year | NCI SEER / ACS estimates |
| CAPItello-291 trial patients w/ CDK4/6 inhibitor history | 69.1% — key real-world context; most patients now receive CDK4/6 inhibitors first-line | FDA, CancerNetwork |
Source: PMC / NCBI Capivasertib review (2022), FDA.gov, AstraZeneca-US.com, Targeted Oncology (April 2026), WHO Global Cancer Observatory, NCI SEER
The patient population mathematics behind capivasertib’s commercial opportunity are striking when laid out systematically. With approximately 2.3 million new breast cancer cases globally each year, around 70% being HR+/HER2–, and approximately 50% of that subgroup harboring AKT pathway alterations, the theoretical global patient pool eligible for capivasertib in its breast cancer indication alone approaches hundreds of thousands of new patients annually. In practice, the relevant population is specifically those who have progressed on prior endocrine therapy — but given the near-universal use of CDK4/6 inhibitor combinations as first-line therapy (reflected in the 69.1% CDK4/6 inhibitor prior use among CAPItello-291 patients), a large and growing cohort of patients is moving into the second-line setting exactly where capivasertib is indicated. Every year that passes without a new first-line option — and the frontline competitive landscape for HR+/HER2– disease remains anchored to CDK4/6 inhibitors — the eligible second-line pool grows.
The prostate cancer opportunity adds a new and potentially substantial dimension to capivasertib’s patient reach. ~9,750 PTEN-deficient mHSPC patients per year in the US is a meaningful number, particularly because this is a population currently receiving no targeted therapy — only the standard abiraterone-ADT backbone. The PTEN-deficiency biomarker, confirmed prospectively using the VENTANA PTEN (SP218) IHC assay in CAPItello-281, also provides a cleaner, simpler companion diagnostic framework than the complex next-generation sequencing required for the breast cancer indication. A pathology IHC test is routinely performed in most urology and oncology practices, removing a potential barrier to biomarker testing that has complicated uptake in the breast cancer setting. If FDA approval follows the ODAC vote, the infrastructure for identifying PTEN-deficient patients and prescribing capivasertib is more straightforward than in the breast cancer context — which could drive faster uptake curves than the breast cancer launch initially achieved.
Capivasertib Safety Profile & Side Effect Statistics in 2026
CAPIVASERTIB ADVERSE EVENT RATES — BREAST vs. PROSTATE CANCER TRIALS
══════════════════════════════════════════════════════════════════════════
Adverse Event BC (CAPItello-291) PC (CAPItello-281)
Any Grade ≥3 AEs Higher vs. placebo 67.0% vs 40.4% (placebo)
Diarrhea (all grade) 72% ███████████████████████ Prominent (all grade)
Diarrhea (Grade ≥3) 9% ██ Higher vs. placebo
Cutaneous rxns 58% ████████████████ Rash: prominent
Cutaneous (Grade ≥3) 17% ████
Hyperglycemia 18% ████ Prominent (incl. DKA 1.2%)
Hyperglycemia (≥3) 2.8% █
SAEs — 42.5% vs 26.0% (placebo)
Discontinuations 13% in AKT-alt. subgroup 18% vs 5% (placebo)
══════════════════════════════════════════════════════════════════════════
| Safety / Adverse Event Metric | CAPItello-291 (Breast Cancer) | CAPItello-281 (Prostate Cancer) |
|---|---|---|
| Any Grade ≥3 Adverse Events | Higher than placebo (detail in labels) | 67.0% (capivasertib) vs. 40.4% (placebo) |
| Diarrhea — All Grades | 72% | Prominent; management-intensive |
| Diarrhea — Grade ≥3 | 9% | Elevated vs. placebo |
| Cutaneous Adverse Reactions — All Grades | 58% | Rash: prominent |
| Cutaneous Adverse Reactions — Grade ≥3 | 17% | Elevated |
| Hyperglycemia — All Grades | 18% | Prominent; DKA in 1.2% of patients |
| Hyperglycemia — Grade ≥3 | 2.8% | Elevated; monitoring required |
| Nausea / Vomiting / Stomatitis | Reported (all grades) | — |
| Serious Adverse Events (SAEs) | — | 42.5% (capivasertib) vs. 26.0% (placebo) |
| Discontinuation due to AE | 13% (in AKT-altered subgroup) | 18% (capivasertib) vs. 5% (placebo) |
| AE-Associated Deaths | — | Numerically higher in capivasertib arm (not statistically analyzed separately) |
| Dose Reductions due to AEs (BC) | 21% of AKT-altered patients required dose reduction | — |
| Dose Interruptions (BC) | 39% of patients in breast cancer indication | — |
| TRUQAP Contraindication | Severe hypersensitivity to capivasertib or any component | — |
| Drug Interaction — Strong CYP3A Inhibitors | Reduce dose to 320 mg BID (4-days-on/3-days-off); avoid if possible | — |
| Embryo-Fetal Toxicity | Can cause fetal harm — animal reproduction studies show adverse outcomes | — |
| Approved Antidote / Reversal Agent | None | — |
Source: AstraZeneca TRUQAP Prescribing Information (updated Nov 2025), FDA Approval Summary (PubMed PMID 39159418), OncLive ODAC live updates (April 30, 2026), Urology Times (April 30, 2026)
The safety profile of capivasertib is one of the most substantive clinical considerations in both its existing breast cancer use and its pending prostate cancer application — and it is the dimension of the drug that generated the most discussion at the April 30, 2026 ODAC meeting. The triad of diarrhea, cutaneous adverse reactions, and hyperglycemia that defines capivasertib’s characteristic toxicity pattern is directly tied to the drug’s mechanism of action: AKT inhibition disrupts insulin receptor signaling (hence hyperglycemia), activates keratinocyte stress responses (hence rash and cutaneous toxicity), and affects intestinal epithelial integrity (hence diarrhea). These are on-target, pathway-mediated toxicities, not off-target effects, which means they are shared by all AKT inhibitors and cannot easily be engineered away without compromising efficacy. The 39% rate of dose interruptions and 21% rate of dose reductions in the breast cancer biomarker-positive population indicate that active monitoring and management protocols are essential to maintaining patients on therapy long enough to derive the PFS benefit.
In the prostate cancer context, where the grade ≥3 adverse event rate reaches 67% and serious adverse events affect 42.5% of capivasertib-treated patients, the safety management burden is substantial. The 1.2% rate of diabetic ketoacidosis (DKA) in CAPItello-281 is a particular concern: DKA is a potentially life-threatening complication that requires immediate medical attention, and its occurrence in a population of prostate cancer patients — who are often older, may have pre-existing metabolic comorbidities, and are simultaneously receiving androgen deprivation therapy (which can worsen insulin resistance) — demands robust patient selection and monitoring protocols. AstraZeneca’s Access 360 program in the US, which supports prior authorization, co-pay assistance, and treatment navigation for Truqap patients, is partly designed to ensure that patients receiving capivasertib are closely supported by healthcare teams equipped to manage these toxicities before they escalate to grade 3 or higher.
Medical Disclaimer: This article is for informational and statistical purposes only and does not constitute medical advice. Patients should consult their oncologist regarding capivasertib eligibility, dosing, and management.
Disclaimer: The data research report we present here is based on information found from various sources. We are not liable for any financial loss, errors, or damages of any kind that may result from the use of the information herein. We acknowledge that though we try to report accurately, we cannot verify the absolute facts of everything that has been represented.
