FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut
- GSK to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut.
- The US first-line indication of Zejula remains unchanged for the 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.
- This decision follows an FDA review of the final OS analysis of the ENGOT-OV16/NOVA Ph 3 trial, which served as the basis for the approval of the second-line maintenance indication. In the final OS results from the NOVA 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.
Share:
More News
“We are pleased to evaluate the clinical combination of IDE892 with RG6505 in MTAP-deleted RAS-mutant PDAC,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. “This collaboration aligns with our broader clinical strategy to evaluate rational combinations with assets in our MTAP-deletion portfolio, and there remains especially high
“In the first reported data from the clinical combinations of our PRMT5 inhibitor vopimetostat and RAS(ON) inhibitors, we saw extremely encouraging early results, with 92% of patients with PDAC in the vopimetostat plus daraxonrasib arm achieving an objective response, supporting the preclinical data showing synergistic activity of PRMT5 + RAS
“Non-small cell lung cancer is the most prevalent lung disease with more than 8,000 patients in the U.S. diagnosed each year with KRAS G12D-mutations. Receiving Fast Track designation for VS-7375 reinforces both the significant unmet need and the potential of VS-7375 to improve outcomes for patients with KRAS G12D-mutated lung
“KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years,” said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. “We believe the proprietary Firelink™ platform will overcome