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AstraZeneca's Truqap Wins FDA Nod for Prostate Cancer Indication
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Key Takeaways
AZN's Truqap gained FDA approval in PTEN-deficient mAPMN/S prostate cancer with abiraterone and prednisone.
AZN's phase III CAPItello-281 study showed a 19% lower risk of progression or death with Truqap.
Truqap Q1 2026 sales rose 47% to $198 million, while EU regulators review the expanded indication.
AstraZeneca PLC (AZN - Free Report) announced that the FDA has approved an expanded use of its breast cancer drug, Truqap (capivasertib), for a prostate cancer indication, making it the first AKT inhibitor approved in a second tumor type.
The FDA has granted approval to Truqap in combination with J&J’s (JNJ - Free Report) Zytiga (abiraterone) and prednisone for the treatment of PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, formerly known as PTEN-deficient metastatic hormone-sensitive prostate cancer. The authority has authorized a companion diagnostic test to identify PTEN deficiency in patients with prostate adenocarcinoma.
Notably, the FDA’s Oncologic Drugs Advisory Committee voted 7-1 in favor of approving Truqap in combination with J&J’s Zytiga and androgen deprivation therapy (ADT) in April for patients with PTEN-deficient mAPMN/S prostate cancer.
AZN already markets Truqap in combination with Faslodex for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer in the United States, the European Union and several other international markets.
Over the past six months, AZN’s shares have lost 2.2% compared with the industry’s 3.8% decline.
Image Source: Zacks Investment Research
Truqap’s Expanded Use Backed by AZN’s CAPItello-281Study
The FDA approval for the label expansion of Truqap was based on positive data from the primary analysis of the ongoing phase III CAPItello-281 study, which demonstrated that Truqap, combined with J&J’s Zytiga and ADT, significantly improved outcomes in patients with PTEN-deficient mAPMN/S prostate cancer. The regimen reduced the risk of disease progression or death by 19% and improved median radiographic progression-free survival by 7.5 months compared with standard treatment.
The Truqap combination is under regulatory review in the European Union for the same indication.
Prostate cancer is the second most prevalent cancer in men globally, with over 1.4 million new cases diagnosed each year. Among patients with mAPMN/S disease, approximately one in four has a PTEN-deficient tumors, a biomarker linked to aggressive disease progression and poorer clinical outcomes.
Truqap was discovered by AstraZeneca in collaboration with Astex Therapeutics.
Truqap recorded sales of $198 million in the first quarter of 2026, up 47% year over year, driven by increased uptake in the U.S. market. The ex-U.S. is market expected to be a key contributor in future quarters. The expanded approval for the prostate cancer indication should drive sales further in coming quarters.
The company is also evaluating Truqap in combination with standard therapies as a first-line treatment for HR-positive breast cancer in the ongoing phase III CAPItello-292 study.
Besides Truqap, AstraZeneca has another prostate cancer therapy, Lynparza, which is marketed in collaboration with Merck under a profit-sharing agreement.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 7.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s earnings per share remained unchanged at $2.97 for 2026 and $4.81 for 2027. LQDA shares have gained 106.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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AstraZeneca's Truqap Wins FDA Nod for Prostate Cancer Indication
Key Takeaways
AstraZeneca PLC (AZN - Free Report) announced that the FDA has approved an expanded use of its breast cancer drug, Truqap (capivasertib), for a prostate cancer indication, making it the first AKT inhibitor approved in a second tumor type.
The FDA has granted approval to Truqap in combination with J&J’s (JNJ - Free Report) Zytiga (abiraterone) and prednisone for the treatment of PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, formerly known as PTEN-deficient metastatic hormone-sensitive prostate cancer. The authority has authorized a companion diagnostic test to identify PTEN deficiency in patients with prostate adenocarcinoma.
Notably, the FDA’s Oncologic Drugs Advisory Committee voted 7-1 in favor of approving Truqap in combination with J&J’s Zytiga and androgen deprivation therapy (ADT) in April for patients with PTEN-deficient mAPMN/S prostate cancer.
AZN already markets Truqap in combination with Faslodex for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer in the United States, the European Union and several other international markets.
Over the past six months, AZN’s shares have lost 2.2% compared with the industry’s 3.8% decline.
Image Source: Zacks Investment Research
Truqap’s Expanded Use Backed by AZN’s CAPItello-281Study
The FDA approval for the label expansion of Truqap was based on positive data from the primary analysis of the ongoing phase III CAPItello-281 study, which demonstrated that Truqap, combined with J&J’s Zytiga and ADT, significantly improved outcomes in patients with PTEN-deficient mAPMN/S prostate cancer. The regimen reduced the risk of disease progression or death by 19% and improved median radiographic progression-free survival by 7.5 months compared with standard treatment.
The Truqap combination is under regulatory review in the European Union for the same indication.
Prostate cancer is the second most prevalent cancer in men globally, with over 1.4 million new cases diagnosed each year. Among patients with mAPMN/S disease, approximately one in four has a PTEN-deficient tumors, a biomarker linked to aggressive disease progression and poorer clinical outcomes.
Truqap was discovered by AstraZeneca in collaboration with Astex Therapeutics.
Truqap recorded sales of $198 million in the first quarter of 2026, up 47% year over year, driven by increased uptake in the U.S. market. The ex-U.S. is market expected to be a key contributor in future quarters. The expanded approval for the prostate cancer indication should drive sales further in coming quarters.
The company is also evaluating Truqap in combination with standard therapies as a first-line treatment for HR-positive breast cancer in the ongoing phase III CAPItello-292 study.
Besides Truqap, AstraZeneca has another prostate cancer therapy, Lynparza, which is marketed in collaboration with Merck under a profit-sharing agreement.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #3 (Hold).
Two better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 7.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, estimates for Liquidia’s earnings per share remained unchanged at $2.97 for 2026 and $4.81 for 2027. LQDA shares have gained 106.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.