The FDA approved Sarclisa, a CD38-targeting monoclonal antibody. The drug will face stiff competition from J&J's Darzalex, which has the same antigen target and is approved for the same population of patients.
The French drugmaker said the agency had accepted its application for isatuximab, a potential competitor to J&J's Darzalex. Positive Phase III data for isatuximab were presented at the ASCO meeting last month.
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