The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior lines of therapy. The approval is based on the response rate and durability of response data from a Phase I/II study and is subject to confirmation from future trials.
Talvey’s Mechanism of Action and Administration
Talvey works by binding CD3 on T cells, guiding the lymphocytes towards GPRC5D expressed on the surface of multiple myeloma (MM) cells. The treatment can be administered weekly or biweekly following an initial step-up phase, offering a flexible treatment option for patients.
Accelerated Approval in the US and Breakthrough Designation in China
Fineline Info & Tech data indicates that the EC’s decision follows the accelerated approval of Talvey in the US earlier this month. Furthermore, the drug is on track to receive a breakthrough therapy designation (BTD) in China for a similar indication, highlighting its potential as a significant treatment option in the global fight against multiple myeloma.-Fineline Info & Tech
