FDA Breakthrough Therapy Designation for Elironrasib for KRAS G12C-mutated locally advanced or metastatic NSCLC

“There continues to be a need for new targeted therapies for patients with RAS-addicted cancers, and this Breakthrough Therapy Designation from the FDA highlights the therapeutic potential of elironrasib, a differentiated inhibitor, for patients with KRAS G12C lung cancer,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Coming shortly after daraxonrasib was granted a designation for patients with advanced RAS mutant pancreatic cancer, this designation for elironrasib further validates our innovative product engine as a source for novel potential treatment approaches for patients with RAS mutant cancers.”

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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