Drugs

GSK Narrows Zejula Indication at FDA’s Request

GSK says it has complied with an FDA request to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The first-line indication remains unchanged for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy, it says.

The narrowed indication comes after an agency review of the final overall survival (OS) analysis of the ENGOT-OV16/NOVA Phase 3 trial, which the company says served as the basis for the approval of the second-line maintenance indication. In the final OS results from this trial, the “secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort,” it says. “The primary endpoint of the NOVA study was progression-free survival (PFS), evaluated as two independently powered cohorts (gBRCAmut and non-gBRCAmut); results demonstrated the clinically meaningful and statistically significant benefit of niraparib in both cohorts and across the HRD [homologous recombination deficiency] subgroups in the non-gBRCAmut cohort."

GSK adds that it is in ongoing discussions about these and other emerging OS data with health authorities worldwide.

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