Two FDA approvals this week advanced targeted treatments into cancer patient populations, as AstraZeneca secured the first biomarker-directed therapy for a specific form of prostate cancer and Merck established a new combination standard in adjuvant kidney cancer.

Truqap wins first targeted approval for PTEN-deficient prostate cancer

FDA approved AstraZeneca's Truqap (capivasertib) in combination with abiraterone and prednisone as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer.¹ The population accounts for roughly one in four of the approximately 200,000 patients worldwide diagnosed with this form of the disease each year, including an estimated 35,000 in the United States.¹

The approval was supported by data from the Phase III Capitello-281 trial, which showed the Truqap combination reduced the risk of radiographic disease progression or death by 19% compared with abiraterone and androgen deprivation therapy plus placebo.¹ The Truqap combination’s median radiographic progression-free survival was 33.2 months versus 25.7 months for the comparator, a 7.5-month improvement.

Overall survival data were immature at the primary analysis but numerically favored the Truqap combination.¹

The approval also designates PTEN deficiency as an actionable biomarker in this setting, with FDA concurrently approving a companion diagnostic to identify PTEN-deficient tumors by immunohistochemistry at the time of diagnosis.¹

"Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer experience faster progression and worse prognosis than those without PTEN deficiency," said Daniel George, MD, director of genitourinary oncology at Duke Cancer Institute and investigator for Capitello-281. "Today's landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and change the course of disease."

The safety profile was broadly consistent with the known profile of each agent, with grade III or higher adverse events occurring in 67% of patients treated with the Truqap combination, including rash (12.3%) and hyperglycemia (10.3%) being the most frequently reported.¹

A regulatory application for the combination in this setting is also under review in the European Union.

Merck’s approvals in adjuvant kidney cancer

FDA approved Keytruda (pembrolizumab) and its subcutaneous formulation Keytruda QLEX, each in combination with Welireg (belzutifan), for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.²

The approvals mark the first time a PD-1 and HIF-2α inhibitor combination has been approved and also represent the first approval for Welireg in earlier-stage ccRCC.

FDA’s decision was based on the Phase III Litespark-022 trial, which enrolled 1,841 patients and demonstrated that Keytruda plus Welireg reduced the risk of disease recurrence, metastasis, or death by 28% compared with Keytruda plus placebo.² The estimated 24-month disease-free survival rate was 81% with the combination versus 74% with Keytruda alone, with median DFS not being reached in either arm, and overall survival data remaining immature.

"The results of the Litespark-022 trial demonstrated the ability of pembrolizumab in combination with belzutifan to reduce the risk of disease recurrence, metastasis, or death by 28%, which represents an important new option for these patients to help keep their clear cell renal cell carcinoma from coming back," said Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute.

Sources

1. Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer AstraZeneca June 12, 2026 https://www.astrazeneca.com/media-centre/press-releases/2026/truqap-approved-in-us-for-prostate-cancer.html
2. FDA Approves Keytruda® (pembrolizumab) and Keytruda Qllex (pembrolizumab and berahyaluronidase alfa-pmph), Each With Welireg® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma Merk June 12, 2026 https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-welireg-belzutifan-for-adjuvant-treatment-of-certain-patients/