Recombinant L-Asparginase not approved in India, conduct CT to study: CDSCO Panel tells Gennova Biopharmaceutical
New Delhi: Highlighting that recombinant L-Asparginase is presently not approved in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Gennova Biopharmaceutical's proposal for waiver of clinical safety and efficacy study of the anticancer drug L- asparaginase-II for Injection 10000IU and recommended to conduct the Phase I/III clinical trials in patients to establish the safety, efficacy and immunogenicity parameters as per the regulatory requirements.
This came after the firm presented a protocol for the conduct of Phase I clinical study titled “A double-blinded, balanced, randomized, single-dose, parallel-group, active-controlled study to compare the pharmacokinetics of the test product GBL19 (recombinant asparaginase, Gennova Biopharmaceuticals Ltd.) with the reference product Spectrila (MedacGmbH) at 5000 IU/m2, in healthy, adult subjects and support modelling and simulation-based extrapolation to paediatrics” vide Protocol number: PR/BE/23/281 version:00 dated 15.09.2023 with a waiver of clinical safety and efficacy study for marketing approval.
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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