FDA fast tracks Amgen myeloma treatment

Dec. 4, 2018

Amgen's AMG420 that targets the BCMA protein linked to multiple myeloma has received fast track status by the U.S. Food and Drug Administration.

The drugmaker's trial of its bispecific antibody for multiple myeloma found that seven out of ten patients given the second-highest dose of AMG420 responded to the drug. Six patients were still responding after more than seven months of follow-up.

Trial patients are hospitalized for their first cycle of AMG420, after which they receive the drug by continuous 24-hour infusion for four weeks, followed by two weeks off therapy, for up to 10 cycles. The highest trial dose was discontinued due to toxicity.

Read the Reuters report