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Johnson & Johnson: a nod from the CHMP

(CercleFinance.com) - Janssen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the novel bispecific antibody TECVAYLI (teclistamab) for the treatment of patients with relapsed and refractory multiple myeloma.


Teclistamab is a bispecific T-cell redirecting antibody. It targets both B-cell maturation antigen (BCMA), a marker found on multiple myeloma cells, and CD3, on T-cells.

The CMA is the approval of a drug that addresses unmet medical needs of patients, based on less complete data than normally required, where the benefit of the drug's immediate availability outweighs the risk and the applicant is able to provide complete clinical data in the future.

The group said that if adopted by the European Commission, this could be the first global authorisation for teclistamab as the first bispecific T-cell redirecting antibody for the treatment of patients with relapsed and refractory multiple myeloma.

The share is up a timid 0.1% in early trading today.



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