FDA is on the fence about GSK multiple myeloma drug

The FDA is a bit leery about an experimental GlaxoSmithKline drug for multiple myeloma, saying on Friday that the side effects may outweigh its benefits. The blood cancer drug, called belantamab mafodotin, has been considered an important asset in GSK’s oncology arsenal, but the FDA pointed out concerns that the drug can cause a form of corneal degeneration called keratopathy. 

Although GSK researchers said that changing the dosage of the medication could help mitigate side effects in the eye, FDA reviewers are not convinced this strategy will be enough. They’re set to meet tomorrow to decide whether the drug should win approval. 

Leerink analyst Geoffrey Porges pointed out in a note that the FDA believes the GSK drug meets an unmet need in multiple myeloma, and is quite effective. 

"We tend to think the members will vote Yes," he wrote.