Lynparza For Pancreatic Cancer: ODAC's Narrow Support Leaves US FDA In Quandary
The Oncologic Drugs Advisory Committee voted 7-5 in favor of AstraZeneca's Lynparza for the treatment of gBRCAm pancreatic cancer, leaving the FDA in a dilemma over how much data to require.
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AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.
Oncologic Drugs Advisory Committee members wondered when Keytruda should be used since cystectomy can be curative and waiting could make the surgery more difficult.
Lynparza doubled PFS in metastatic patients with germline mutations in BRCA but the FDA usually wants to see OS data before approving drugs for pancreatic cancer. Its advisory committee narrowly voted in favor of approval of the PARP inhibitor but will the agency follow suit?