MSN Lab Gets CDSCO Panel Nod to Manufacture, Market Nelarabine Injection
New Delhi: In a significant development, the drug major MSN Laboratories has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Nelarabine Injection 250mg/50mL for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
However, this approval is subject to the condition that the drug should be sold by retail under the prescription of an oncologist only. Furthermore, the expert panel suggested that the firm The firm should conduct Phase-IV clinical trial.
This came after the drug major MSN Laboratories presented the proposal for the manufacture and marketing of Nelarabine Injection 250mg/50mL (5 mg/mL) along with a request for bioequivalence (BE) waiver and 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.
Nelarabine is a pro-drug of the deoxyguanosine analogue 9-β-D- arabinofuranosylguanine (ara-G). Nelarabine is demethylated by adenosine deaminase (ADA) to ara-G, mono-phosphorylated by deoxyguanosine kinase and deoxycytidine kinase, and subsequently converted to the active 5'-triphosphate, ara-GTP, resulting in the inhibition of DNA synthesis and cytotoxicity.
At the recent SEC meeting for Oncology and Hematology held on 8th June 2023, the expert panel reviewed the proposal presented by drug major MSN Laboratories for the manufacture and marketing of Nelarabine Injection 250mg/50mL (5 mg/mL) along with a request for BE waiver and local Phase III clinical trial waiver.
The committee noted, "The drug is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses."
In addition to the above, the expert panel noted that randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
The committee also pointed out that the medicine is an Orphan medicine in the USA and the EU.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Nelarabine Injection 250mg/50mL (5 mg/mL) with BE waiver and 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 Phase-IV clinical trial.
Accordingly, the expert panel advised that the firm should submit the Phase IV clinical trial protocol to CDSCO for further review by the committee.
