Supplemental BLA submitted to FDA Seeking Approval of RYBREVANT + Chemo in EGFRm NSCLC Patients Who Progressed on or after Osimertinib

“New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for RYBREVANT in this expanded patient population.”

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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