FDA Panel Tentative Yes To AZ’s Lynparza In Pancreatic Cancer
OS Data An Issue, EU Extension Also Under Review
Executive Summary
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?
You may also be interested in...
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.
AstraZeneca's Risky Lynparza Endpoint In Pancreatic Cancer Goes Before Advisory Cmte.
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 Failure For Biohaven’s Troriluzole
Biohaven’s investigational glutamate modulator troriluzole did not improve symptoms in patients with mild-to-moderate disease, adding to the list of failures in Alzheimer’s disease, as well as for the product itself.
Need a specific report? 1000+ reports available
Buy Reports