FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations
“We’re working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in our path to resolution,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D. Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson. “Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT – both as a standalone treatment and in combination with LAZCLUZE – for EGFR-mutated advanced lung cancer. We’re proud to have helped so many patients in the front-line setting already with RYBREVANT and look forward to further expanding treatment options with our subcutaneous formulation pending regulatory review and approval.”
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“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