CHMP backing puts J&J’s CD3 x BCMA bispecific on cusp of approval

A recommendation by EMA’s CHMP for the conditional approval of Tecvayli teclistamab, J&J’s CD3 x BCMA bispecific antibody for MM, was among the positive opinions for new medicines in July.

It’s the first T cell redirecting bispecific antibody to treat relapsed and refractory MM to receive backing by the agency, according to Johnson & Johnson (NYSE:JNJ). The therapy, which has PRIority MEdicines (PRIME) designation from EMA and is under review for use as monotherapy to treat fourth-line relapsed and refractory multiple myeloma, has yet to receive FDA approval. The PDUFA date is undisclosed...