The U.S. Food and Drug Administration has approved AstraZeneca's (NASDAQ: AZN) Truqap in combination with abiraterone and prednisone for treating adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer.

The approval makes Truqap the first targeted treatment specifically for this patient population, which must be identified through an FDA-authorized test. The treatment targets patients with PTEN-deficient tumors, representing approximately one in four cases of this form of prostate cancer.

The FDA decision was based on results from the CAPItello-281 Phase III trial, which showed a 19% reduction in the risk of radiographic disease progression or death. Patients receiving the Truqap combination achieved a median radiographic progression-free survival of 33.2 months compared to 25.7 months for those receiving abiraterone with placebo.

Approximately 35,000 patients in the U.S. are diagnosed annually with metastatic androgen pathway modulation-naïve or sensitive prostate cancer, with about 200,000 cases worldwide. PTEN deficiency occurs in roughly 25% of these patients and is associated with more aggressive disease progression.

The trial data showed grade 3 or higher adverse events in 67% of patients receiving the Truqap combination, with rash and hyperglycemia being the most frequently reported serious side effects.

The FDA simultaneously approved a companion diagnostic test to detect PTEN deficiency in prostate adenocarcinoma tumors. AstraZeneca has submitted a regulatory application for the treatment combination to European authorities, which remains under review.

The information is based on a company press release announcing the regulatory approval.