Drugs

FDA OKs Akeega for BRCA2-Mutated Metastatic Prostate Cancer

FDA has approved Janssen’s Akeega — a fixed-dose combination of niraparib and abiraterone acetate — with prednisone for adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring deleterious or suspected deleterious BRCA2 mutations. The approval requires use of an FDA-authorized companion diagnostic to confirm BRCA2 status.

The decision marks the first U.S. approval of a PARP inhibitor–abiraterone combination in the front-line metastatic castration-sensitive setting for a molecularly selected prostate cancer subgroup, according to an FDA release.

FDA based its decision on data from the Phase 3 AMPLITUDE study (NCT04497844), a 696-patient, randomized, double-blind trial comparing niraparib plus abiraterone/prednisone (AAP) against placebo plus AAP, FDA says. The study’s primary endpoint, radiographic progression-free survival (rPFS), was met in the overall homologous recombination repair gene–mutated population, but the agency highlighted that the magnitude of benefit was largely concentrated among the 323 patients with BRCA2 mutations. In that subgroup, niraparib plus AAP cut the risk of radiographic progression or death by 54% versus control.

Additionally, FDA saya Akeega’s prescribing information includes warnings for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, hypokalemia, fluid retention and cardiovascular adverse reactions, hepatotoxicity, adrenocortical insufficiency, hypoglycemia, increased fractures and mortality when used with radium-223, posterior reversible encephalopathy syndrome, and embryo-fetal toxicity.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome