Truqap combo wins new US approval in PTEN-deficient prostate cancer
100% citation coverage2 regulatory sources
The FDA has approved AstraZeneca’s Truqap combination with abiraterone and prednisone for PTEN-deficient mAPMN/S prostate cancer. The decision was based on CAPItello-281 Phase III results and positions the regimen as the first and only targeted option in this setting.
Intelligence Snapshot
Executive Summary
The US Food and Drug Administration approved AstraZeneca's Truqap (capivasertib) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, marking the first and only targeted treatment for this biomarker-def
Key Insights
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The approval was supported by positive Phase III results from the CAPItello-281 trial,…
The approval was supported by positive Phase III results from the CAPItello-281 trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
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The new indication adds to capivasertib's existing FDA label in breast cancer , where the…
The new indication adds to capivasertib's existing FDA label in breast cancer , where the oral kinase inhibitor is indicated in combination with fulvestrant for HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations .
Market Impact
| Regulatory | high |
|---|---|
| Commercial | high |
| Competitive | medium |
| Investment | high |
The FDA has approved AstraZeneca's Truqap combination with abiraterone and prednisone for PTEN-deficient mAPMN/S prostate cancer. The decision was based on CAPItello-281 Phase III results presented at the 2025 European Society for Medical Oncology (ESMO) Congress, positioning the regimen as the first and only targeted option in this setting.
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Quick Answer
Key Questions
- What is the approved indication for Truqap in prostate cancer?
- What clinical evidence supported the prostate cancer approval?
- What is capivasertib's existing FDA-approved indication?
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Explore drug hub →Contents13 sections
Truqap Combo Wins New US Approval in PTEN-Deficient Prostate Cancer
Key Takeaways
- The US Food and Drug Administration approved AstraZeneca's Truqap (capivasertib) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, marking the first and only targeted treatment for this biomarker-defined population.
- The approval was supported by positive Phase III results from the CAPItello-281 trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
- The new indication adds to capivasertib's existing FDA label in breast cancer, where the oral kinase inhibitor is indicated in combination with fulvestrant for HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations.
IntelligenceRegulatory Impact
FDA and EMA decisions frame this story. Regulatory relevance is high for Oncology, with Truqap and capivasertib most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
FDA Approval for PTEN-Deficient Prostate Cancer
The US Food and Drug Administration approved AstraZeneca's Truqap (capivasertib) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The regimen is approved as the first and only targeted treatment for this patient population.
Prior to this approval, capivasertib was FDA-indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
IntelligenceCompetitive Intelligence
AstraZeneca are directly implicated. Competitive pressure reads medium — compare pipeline positioning and partnership scouting against signals in this story.
CAPItello-281 Phase III Trial
The FDA approval of the Truqap combination for PTEN-deficient mAPMN/S prostate cancer was based on results from the CAPItello-281 Phase III trial. The trial results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
IntelligenceMarket Signals
Commercial pull is high and investment relevance high for Oncology. Expect implications for pricing, access, and launch sequencing.
Regulatory Context
Capivasertib is a kinase inhibitor with an oral route of administration, manufactured by AstraZeneca Pharmaceuticals LP. The drug now carries two distinct FDA-approved indications: breast cancer in combination with fulvestrant, and prostate cancer in combination with abiraterone and prednisone. Each indication is defined by specific biomarker criteria—PIK3CA/AKT1/PTEN alterations in breast cancer and PTEN deficiency in the prostate cancer setting.
IntelligenceStrategic Takeaways
The US Food and Drug Administration approved AstraZeneca's Truqap (capivasertib) in combination with abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, marking the first and only targeted treatment for this biomarker-def The approval was supported by positive Phase III results from the CAPItello-281 trial, presented at
Drug Snapshot
| Drug | capivasertib |
|---|---|
| Generic name | CAPIVASERTIB |
| Manufacturer | AstraZeneca Pharmaceuticals LP |
| Route | ORAL |
| Indication | 1 INDICATIONS AND USAGE TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients |
IntelligenceEvidence Quality
Grounded in 2 regulatory sources.
Regulatory Summary
- Approved indication: 1 INDICATIONS AND USAGE TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients
- AstraZeneca Pharmaceuticals LP develops capivasertib
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT05563220 | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer | ACTIVE_NOT_RECRUITING | PHASE1, PHASE2 | Stemline Therapeutics, Inc. |
| NCT06982521 | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer | RECRUITING | PHASE3 | Relay Therapeutics, Inc. |
| NCT02465060 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | ACTIVE_NOT_RECRUITING | PHASE2 | National Cancer Institute (NCI) |
| NCT03660826 | Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone | ACTIVE_NOT_RECRUITING | PHASE2 | National Cancer Institute (NCI) |
| NCT04439123 | Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) | ACTIVE_NOT_RECRUITING | PHASE2 | National Cancer Institute (NCI) |
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| West Virginia University | Oncology | 1 |
| M.D. Anderson Cancer Center | Oncology | 1 |
| National Cancer Institute (NCI) | Oncology | 1 |
| Methodist Health System | Oncology | 1 |
| Women's College Hospital | Oncology | 1 |
| City of Hope Medical Center | Oncology | 1 |
Timeline
- Active_Not_Recruiting trial NCT05563220 (PHASE1, PHASE2)
- Recruiting trial NCT06982521 (PHASE3)
- Active_Not_Recruiting trial NCT02465060 (PHASE2)
- Active_Not_Recruiting trial NCT03660826 (PHASE2)
- Active_Not_Recruiting trial NCT04439123 (PHASE2)
Frequently Asked Questions
What is the approved indication for Truqap in prostate cancer?
Truqap (capivasertib) in combination with abiraterone and prednisone is approved for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer.
What clinical evidence supported the prostate cancer approval?
The FDA approval was based on positive Phase III results from the CAPItello-281 trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
What is capivasertib's existing FDA-approved indication?
Capivasertib is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations.
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- Sources analyzed
- 1
- Evidence strength
- 94/100
- Last verified
- Jun 14, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
Critical source quality · grounded in cited primary and secondary sources.
Sources & references 1 primary sources
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