US FDA approval tracker: July

Last month saw three early FDA approvals, including that of Morphosys and Incyte’s Monjuvi, an anti-CD19 antibody that last week won a better-than-expected second line label to treat large B-cell lymphoma. With the filgotinib verdict yet to emerge for Gilead and Galapagos, Monjuvi becomes the most notable new approval in terms of sales potential for July – filgotinib received a positive opinion in Europe and hopes are high for a green light in the US in August. A second Car-T approval also arrived early for Gilead. KTE-X19, now branded Tecartus, was waved through in mantle cell lymphoma. Other big decisions in the US last month included Jazz’s new narcolepsy treatment, Xywav; this is a low sodium follow-on to Xyrem, which will see generic competition in 2023, so Jazz needs to make the most of the Xyway opportunity. GW Pharma meanwhile added tuberous sclerosis to the label for Epidiolex, putting more ground between it and competitor Zogenix. And GSK’s anti-BCMA ADC, belantamab mafadotin, got a positive adcom vote for myeloma, despite underwhelming efficacy and safety issues. This makes an approval likely in August, although black box warnings and a REMS programme will likely be required (Go or no go? Valuable drugs set for FDA decisions, July 29, 2020).