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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-21T18:00:09+05:30 | Updated On 21 Jun 2024 6:00 PM IST

Zydus Lifesciences arm application for Menkes disease treatment gets USFDA priority review

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.

At the recent SEC meeting for oncology held on June 5th and 6th, 2024, the expert panel reviewed the proposal for the manufacture and marketing of Nelarabine Injection 250 mg/50 mL (5 mg/mL), along with a request for a bioequivalence (BE) waiver and a local Phase III clinical trial waiver.

The committee noted that the drug is approved in the USA and EU as an orphan drug.

After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Nelarabine Injection 250 mg/50 mL (5 mg/mL) with a BE waiver and a local Phase III clinical trial waiver subject to the following conditions:

1. The drug should be sold by retail under the prescription of an oncologist only.

2. The firm should conduct a Phase-IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within three months of approval for further review by the committee.

Also Read:Zuventus Healthcare gets CDSCO Panel Nod To Manufacture, Market Edoxaban film-coated tablets

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751