FDA Panel Tentative Yes To AZ’s Lynparza In Pancreatic Cancer
OS Data An Issue, EU Extension Also Under Review
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?
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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.
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca chose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.
Another disappointment for irritable bowel syndrome therapies as Urovant Science’s vibegron fails in a Phase II trial, likely spelling the end for the investigational indication.