June 16 Quick Takes: Roche wins bispecific approval
Plus: FDA extends momelotinib’s review, and Neuvivo raises cash
Roche (SIX:ROG; OTCQX:RHHBY) intends to launch newly approved bispecific antibody Columvi glofitamab in the coming weeks after FDA granted the bispecific antibody accelerated approval to treat third-line diffuse large B cell lymphoma. The approval was based on response rates in a Phase I/II trials in which 30% of patients had previously received CAR T therapy. Columvi will compete with fellow CD3 x CD20 bispecific Epkinly epcoritamab from AbbVie Inc. (NYSE:ABBV) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB), which received accelerated approval in the setting last month. Epkinly’s response rates were slightly higher than Columvi’s in clinical testing, but Columvi has the advantage of being developed as a fixed-dose course of treatment. Both bispecifics offer an off-the-shelf alternative to CAR Ts.
GSK plc (LSE:GSK; NYSE:GSK) is now looking ahead to a Sept. 16 PDUFA date for momelotinib after FDA extended its review to assess additional data submitted by the pharma. The inhibitor of JAK1, JAK2 and ALK2 is under review to treat myelofibrosis; GSK obtained the candidate via its $1.9 billion buyout of Sierra Oncology Inc. last year. Its PDUFA date was June 16...