Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee — has a well-known bias in fa­vor of adding new can­cer drugs to the mar­ket, even if ef­fi­ca­cy is at best mar­gin­al and se­ri­ous safe­ty is­sues de­mand care­ful man­age­ment.

Doc­tors want as many ar­rows in their quiver as they can get. And when pa­tients are dy­ing af­ter fail­ing mul­ti­ple drugs, why not give it a go one more time?

Glax­o­SmithK­line, though, is about to test out how their new BC­MA an­ti­body drug con­ju­gate be­lan­tam­ab mafodotin can do af­ter be­ing mauled in an in-house FDA re­view, ahead of the Tues­day ex­pert pan­el dis­cus­sion. Even if the agency goes ahead with an ex­pect­ed green light, this drug will like­ly be con­strained to a small niche — ic­ing any plans they may have for mak­ing waves in on­col­o­gy any­time soon.

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