Harpreet Singh: FDA Grants Breakthrough Therapy To Daraxonrasib For KRAS G12+ Metastatic Pancreatic Cancer
Harpreet Singh, Chief Medical Officer at Precision For Medicine, shared a post on LinkedIn:
“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.
In this edition of CMO Confidential, I share details on this exciting regulatory milestone and what to watch as the trial progresses.”
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