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FDA Grants Breakthrough Therapy To Daraxonrasib

FDA Grants Breakthrough Therapy To Daraxonrasib For KRAS G12+ Metastatic Pancreatic Cancer

The FDA has granted Breakthrough Therapy Designation to Revolution Medicines’ daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring KRAS G12 mutations

This designation is based on encouraging early data from the Phase 1 RMC-6236-001 trial and enables FDA’s Division of Oncology 3 to frequently engage with and provide guidance to the sponsor.

More than 90% of PDAC cases carry a RAS mutation and for the ~85% with KRAS G12 mutations, new treatment options are urgently needed. Breakthrough designation creates a pathway for earlier, more frequent engagement with the FDA, with the goal of getting safe, effective therapies to patients faster.

RMC-6236 is an orally active, non-covalent RAS (ON) inhibitor. RMC-6236 disrupts the interaction of wild-type or mutant RAS proteins with the RAS binding domain of BRAF, with EC50 values ranging from 28-220 nM for wild-type KRAS, NRAS, HRAS, and multiple oncogenic RAS variants. RMC-6236 inhibits pERK. RMC-6236 has anti-tumor activity against KRAS mutant tumors.

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