Johnson and Johnson Gets CDSCO Panel Nod for Talqetamab in Relapsed Multiple Myeloma, Phase IV Trial Mandated
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to Johnson & Johnson Pvt. Ltd. to import and market Talqetamab solution for injection 2 mg/ml and 40 mg/ml, with a Phase III local clinical trial waiver, subject to the condition that the firm conducts a Phase IV clinical trial in India.
The recommendation was made under file number BIO/CT18/FF/2024/46258.
The decision follows earlier SEC recommendations dated 21.05.2025, after which the firm submitted additional justification addressing the unmet medical need in India, along with efficacy results from extended global clinical trials. The firm also provided a formal commitment to conduct a Phase IV study in India to support its proposal.
During deliberations, the committee noted that Talqetamab demonstrates a significant therapeutic advancement over the current standard of care for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have shown disease progression on the last therapy.
After detailed assessment, the SEC recommended permission to import and market Talqetamab for the indication: “treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy”, in line with the EMA-approved indication.
The committee, however, made it mandatory for the firm to conduct a Phase IV clinical trial in a significant number of Indian patients. It further directed that the Phase IV clinical trial protocol must be submitted to CDSCO within three months of grant of marketing authorisation approval.
Talqetamab is a bispecific antibody therapy developed for heavily pre-treated multiple myeloma patients with limited therapeutic options, and the SEC’s recommendation reflects the regulatory emphasis on generating post-marketing Indian clinical data for novel oncology therapies.
