Revolution Medicines’ Daraxonrasib Granted FDA Breakthrough Therapy Designation for Pancreatic Cancer with KRAS G12 Mutations

Revolution Medicines Inc. (NASDAQ:RVMD) is one of the most promising stocks according to Wall Street analysts. On June 23, Revolution Medicines announced that the US FDA granted Breakthrough Therapy Designation to daraxonrasib (RMC-6236). This designation is for daraxonrasib, which is a RAS(-ON) multi-selective inhibitor, for the treatment of previously treated metastatic pancreatic ductal adenocarcinoma/PDAC in patients with KRAS G12 mutations.

The Breakthrough Therapy Designation was based on encouraging early clinical evidence from the Phase 1 RMC-6236-001 clinical trial, which evaluated daraxonrasib in patients with previously treated metastatic PDAC. Pancreatic cancer is a highly lethal malignancy, with PDAC accounting for ~92% of all cases.

Revolution Medicines' Daraxonrasib Granted FDA Breakthrough Therapy Designation for Pancreatic Cancer with KRAS G12 Mutations

A researcher poring over test results, illustrating the breakthrough potential of biotechnology.

In 2024, an estimated 60,000 people in the US will be diagnosed with pancreatic cancer, and about 50,000 will die from it. Over 90% of PDAC tumors carry a RAS cancer driver mutation, with ~85% having a KRAS G12 mutation. The 5-year survival rate for metastatic PDAC is about 3%.

Revolution Medicines Inc. (NASDAQ:RVMD) is a clinical-stage precision oncology company that develops novel targeted therapies for RAS-addicted cancers.

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Disclosure: None. This article is originally published at Insider Monkey.