Recombinant L-Asparginase not approved in India, conduct CT to study: CDSCO Panel tells Gennova Biopharmaceutical

The committee noted that recombinant L-asparaginase is presently not approved in India. Furthermore, the expert panel stated that the safety, efficacy, and PK/PD parameters of the test product need to be compared with the innovator product in multiple dosing regimens in patients to establish the safety and efficacy of the applied product.

L- asparaginase-II is used in the treatment of some kinds of cancer of white blood cells (leukemia). It may also be used to treat other types of cancer as determined by your doctor. It may be used on its own, or sometimes given together with certain other medicines as part of combination chemotherapy.

L- asparaginase-II is an Antineoplastic agent. Asparaginase is an enzyme that breaks down asparagine. Unlike normal cells, all cells are unable to make their asparagine. So asparaginase stops the cancer cells from dividing and growing.

At the recent SEC meeting for Oncology and Hematology held on 7th and 8th December 2023, the expert panel reviewed the Phase I protocol of the anti-cancer drug L- asparaginase-II.

After detailed deliberation, the committee recommended the firm conduct Phase I/III clinical trials in patients to establish the safety, efficacy, and immunogenicity parameters as per the regulatory requirements.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for further deliberation before the committee.

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