CDSCO Panel Rejects Roche Products India local Phase III CT waiver proposal for Atezolizumab injection SC route

New Delhi: Recommending to conduct a phase III study in the Indian population to establish the safety and efficacy, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the proposal of Roche Products (India) for approval of Atezolizumab injection (1875 mg/15 ml) (Tecentriq) for the proposed subcutaneous route (S.C.) route of administration with waiver of the phase III clinical trial.

This occurred as the proposal of the firm was redeliberated for the grant of permission to import and market Atezolizumab injection (1875 mg/15 ml vial) (Tecentriq) by a new route of administration, i.e., a subcutaneous route for indications of Atezolizumab injection approved for intravenous (IV) route for sale or for distribution in India, with a local phase III clinical trial waiver under unmet need in India and a commitment to conduct a Phase IV study.

Atezolizumab is a monoclonal antibody used to treat advanced or metastatic urothelial carcinoma with disease progression during or up to 12 months after platinum-containing chemotherapy.

Atezolizumab is a humanized IgG antibody that binds PD-L1, preventing its interaction with PD-1 and B7-1. Preventing the interaction of PD-L1 and PD-1 removes inhibition of immune responses, such as the anti-tumor immune response but not antibody-dependent cellular cytotoxicity

At the recent SEC meeting for Oncology held on May 15, 2024, the expert panel redeliberated the proposal for the grant of permission to import and market Atezolizumab injection (1875 mg/15 ml vial) (Tecentriq) by new route of administration, i.e., subcutaneous route (S.C.) for indications of Atezolizumab injection approved for intravenous (IV) route for sale or for distribution in India, with local Phase III clinical trial waiver under unmet need in India and commitment to conduct Phase IV study.

The committee noted that the intravenous (IV) formulation of Atezolizumab is already available on the market.

Furthermore, the committee noted that the formulation and dose of the proposed S.C. route are different from the intravenous (IV) route, and India was not part of the global clinical trials (GCT) conducted to establish safety and efficacy data for the new route of administration, i.e., the S.C. route.

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