Keeping Track: Three Oncologics, A New Migraine Preventive, And First LPAD Antibiotic Clear US FDA
The latest drug development news and highlights from our FDA Performance Tracker.
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Adverse trend in overall survival, tolerability concerns, and uncertainty regarding the dose suggest the PI3K inhibitor's benefit-risk profile in its current indications is unfavorable, FDA says. Secura Bio asserts OS data are confounded and safety issues are the same as at initial approval.
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.