Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine

New Delhi: In a significant development, the drug major Zydus Life Science has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the anti-cancer drug Nelarabine Injection 250 mg/50 mL (5 mg/mL).

However, this approval is subject to the condition that the drug should be sold by retail under the prescription of an oncologist only, and the firm should conduct a Phase IV clinical trial.

This came after the firm presented their proposal for the manufacture & marketing of Nelarabine Injection 250 mg/50 mL (5 mg/mL), along with a request for a BE waiver and a local Phase III clinical trial waiver.

Nelarabine is a purine nucleoside analog and antineoplastic agent used for the treatment of acute T-cell lymphoblastic leukemia and T-cell lymphoblastic lymphoma with inadequate clinical response to prior chemotherapeutic treatments.

The drug is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

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