Roche's proposal for marketing Atezolizumab Injection for Subcutaneous route rejected by CDSCO Panel
New Delhi: Rejecting the drug major Roche's proposal to market the anti-cancer drug Atezolizumab Injection (1875mg/15ml vial) (Tecentriq) for a new route of administration i.e., subcutaneous route, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct Phase III study to establish safety and efficacy of Atezolizumab for new route of administration i.e., Subcutaneous route.
This came after the firm presented their proposal for grant of permission to import and market Atezolizumab Injection (1875mg/15ml vial) (Tecentriq) by new route of administration i.e., subcutaneous route for indications of Atezolizumab injection approved for Intravenous (IV) route for sale or for distribution in India with local Phase III and Phase IV clinical trial waiver for under unmet need in India.
Atezolizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the person's immune system fight against the cancer cells and helps to slow tumor growth.
Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumors have been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1.
At the recent SEC meeting for Oncology held on 9th and 10th January 2024, the expert panel reviewed the proposal to import and market the anti-cancer drug Atezolizumab injection (1875mg/15ml vial) (Tecentriq) for new route of administration i.e., subcutaneous (SC) route for indications of Atezolizumab injection approved for Intravenous (IV) route for sale or for distribution in India with local Phase III and Phase IV clinical trial waiver for under unmet need in India.
The committee noted that the IV formulation of Atezolizumab is already available in the market.
Furthermore, the committee noted that the formulation and dose of the proposed SC route are different from the IV route and also India was not part of the global clinical study conducted to establish safety and efficacy data for the new route of administration i.e. SC route.
After detailed deliberation, the committee did not consider the firm’s request for approval of Atezolizumab Injection (1875mg/15ml vial) (Tecentriq) by the proposed SC route of administration with the waiver of the local clinical trial.
In line with the above, the expert panel recommended that the firm should conduct a Phase III study to establish the safety and efficacy of the product for the proposed subcutaneous (SC) route.
