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.

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US FDA's ODAC will review four cancer drugs in two days. • Source: Shutterstock

The US Food and Drug Administration will close out 2019 with a two-day Oncologic Drugs Advisory Committee meeting encompassing four applications – two for supplemental indications and two original submissions – in mid-December.

On the morning of 17 December, ODAC will discuss the addition of a pancreatic cancer indication for AstraZeneca PLC and Merck & Co. Inc.’s PARP inhibitor Lynparza (olaparib)

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