AstraZeneca announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of the supplemental new drug application for Truqap (capivasertib) in metastatic hormone‑sensitive prostate cancer. The proposed indication is for Truqap in combination with abiraterone acetate and prednisone for the treatment of adult patients 18 years and older with PTEN‑deficient de novo metastatic hormone‑sensitive prostate cancer, as detected by an FDA‑approved circulating tumor DNA test.
The committee voted 7 to 1 that the benefits of Truqap plus abiraterone and prednisone outweigh the risks for this patient population. The recommendation was based on data from the Phase 3 CAPItello‑281 trial, which evaluated capivasertib plus abiraterone and prednisone versus placebo plus abiraterone and prednisone in patients with PTEN‑deficient metastatic hormone‑sensitive prostate cancer.
In CAPItello‑281, treatment with capivasertib improved radiographic progression‑free survival compared with placebo, meeting the trial’s primary endpoint. Median radiographic progression‑free survival was 33.2 months with capivasertib versus 25.7 months with placebo, corresponding to a hazard ratio of 0.81. Overall survival data were not mature at the time of the analysis.
The ODAC’s vote is advisory, and the FDA will consider the committee’s recommendation in its review of the supplemental new drug application for Truqap in PTEN‑deficient metastatic hormone‑sensitive prostate cancer.
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