J&J Gets CDSCO Panel Nod to study anti-cancer drug Talquetamab

New Delhi: The drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical study of the anti-cancer drug Talquetamab.

This came after the firm presented Phase III Clinical Study Protocol No. 64407564MMY3009.

Talquetamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma.

Talquetamab is an IgG4-PAA bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager. It consists of two arms – anti-GPRC5D and anti-CD3 arms – linked by two interchain disulfide bonds, each arm comprising a heavy and light chain. Talquetamab binds to GPRC5D, a cell surface receptor expressed predominantly on multiple myeloma cells, and CD3 on T cells. It works to recruit CD3-expressing T cells to GPRC5D-expressing multiple myeloma cells to induce T-cell–mediated cytotoxicity.

At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase III Clinical Study Protocol of the anti-cancer drug Talquetamab presented by drug major Johnson and Johnson.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
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