Drugs

Pfizer’s Talzenna Gets Updated Label

FDA has approved updated labeling on Pfizer’s s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastatic castration-resistant prostate cancer (mCRPC). “The FDA approved updated labeling with the inclusion of final overall survival (OS) data for the combination’s existing indication for the treatment of adults with homologous recombination repair (HRR) gene-mutated mCRPC but did not expand the indication to include patients with non-HRR gene-mutated mCRPC,” the company says.

The update was supported by the positive data from the Phase 3 TALAPRO-2 trial, which Pfizer says demonstrated a statistically significant and clinically meaningful improvement in OS in patients with HRR-mutated mCRPC. “The FDA noted that the trial was not sufficient to conclude a favorable benefit-risk profile to expand the indication in the subgroup of patients with non-HRR gene mutated mCRPC,” it says. Based on the agency’s decision, Pfizer says it will no longer pursue an expanded indication for the combination in mCRPC in the U.S.

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

Read more

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