Submit global regulatory status of Atezolizumab for IV, SC route: CDSCO Panel Tells Roche Products India

New Delhi: In response to the proposal presented by the drug major Roche Products India for granting permission to import and market Atezolizumab injection (1875mg/15ml vial) (Tecentriq) by 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 submit the global regulatory status of the drug Atezolizumab for IV and SC route of administration along with indication.

This came after the proposal of the firm has been re-deliberated for the 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 clinical trial waiver under unmet need in India and commitment to conduct 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 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.

Inhibition of PD-L1 by atezolizumab can remove this inhibitor effect and thereby engender an anti-tumor response. It is one of several ways to block inhibitory signals related to T-cell activation, a more general strategy known as "immune checkpoint inhibition."

At an earlier SEC meeting dated 09.01.2024, the drug major Roche Products India presented a proposal for granting 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 distribution in India with local Phase III and Phase IV clinical trial waiver for under unmet need in India.

The committee noted that the i.v formulation of Atezolizumab was already available in the market and the formulation and dose of the proposed s.c route was different from the i.v route. Furthermore, the committee found that India was not part of the global clinical study conducted to establish safety and efficacy data for the new route of administration i.e. s.c route.

In line with the above observation, the expert panel opined the firm to conduct a Phase III study to establish the safety and efficacy of the product for the proposed SC route.

Now, in continuation with the above, at the recent SEC meeting dated 19.03.2024 and 20.03.2024, the proposal of the firm has been redeliberated.

After detailed deliberation, the committee recommended the following:

1. The firm should submit the global regulatory status of the drug for IV and SC route of administration along with indication.

2. The firm should clarify the reason for the withdrawal of indications by USFDA along with its current status.

Accordingly, the expert panel suggested that the firm should submit the above clarifications to CDSCO for further evaluation by the committee.

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