CDSCO panel opines Johnson and Johnson to submit details of anticancer drug Teclistamab nod in EU, US

In response to the drug major Johnson & Johnson proposal to import and market Teclistamab sterile liquid in vial 30mg/vial and 90mg/vial, the Subject Export Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit patients characteristics along with transplant history if any, treatment details and details of approval of the drug in EU and US for further deliberation.

This came after the firm presented the proposal to import and market Teclistamab sterile liquid in vials 30mg/vial and 90mg/vial indicated for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody with local clinical trial waiver.

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CDSCO Opines J&J To Submit Details Of Anticancer Drug Teclistamab Approval In EU, US