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US FDA Fine-Tunes Tecentriq, Keytruda First-Line Bladder Cancer Accelerated Approval Indications

Executive Summary

FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling. 

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Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.

Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review

AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.

Nektar/Bristol Show Promise With Double IO Combo, But Numbers Are Small

Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.

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