The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM).
Promising Efficacy in Phase I Trials
Forimtamig is a bispecific antibody (BsAb) designed to target GPRC5D and CD3. In a Phase I clinical study involving heavily pre-treated patients with recurrent or refractory multiple myeloma, forimtamig demonstrated promising efficacy and manageable safety. The objective response rate (ORR) was reported at 71.4%, with 52.4% of participants achieving a good partial response. These compelling results were presented at the 2022 European Hematology Association (EHA) annual meeting, highlighting the potential of forimtamig as a viable treatment option for this challenging condition.
Next Steps for Roche in Multiple Myeloma Treatment
With tacit approval in hand, Roche is poised to advance its clinical trials for forimtamig, potentially paving the way for a new therapeutic avenue in the management of multiple myeloma. This development underscores Roche’s commitment to addressing unmet medical needs in hematologic malignancies and enhancing patient outcomes.-Fineline Info & Tech
