Anti-BCMA Therapies Aim To Raise The Bar In Myeloma
ASCO Offers Stage For New Data For CAR-T And ADC Candidates
GSK’s antibody-drug conjugate may reach the market first, but CAR-T therapies from Bristol/bluebird and Janssen/Legend are close behind, and all three big pharmas have programs in earlier-stage disease.
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A number of drug companies are set to learn the fate of their marketing authorization applications in the EU this week.
The US FDA took issue with the CMC portion of the BLA for the BCMA-targeted therapy idecabtagene vicleucel for multiple myeloma. An approval is tied to a $9 CVR for Celgene shareholders.
GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.