Roche's Polivy ADC Is Approved As Another New Option For R/R DLBCL
The first-in-class anti-CD79b antibody-drug conjugate received a swift accelerated approval by the US FDA based on the results of a Phase Ib/II trial, for the same setting as CAR-T agents.
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Oncology is an area where the Swiss major has long been a dominant player, and Bill Anderson highlighted programs to Scrip which Roche hopes will help extend that dominance.
Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.
The antibody-drug conjugate yields a 48% overall and 24% complete response rate in a pivotal Phase II DLBCL study. The Swiss biotech hopes to compete with Polivy and is studying combo therapy with Imbruvica.