CDSCO Panel Seeks Revised Phase IV Trial Protocol for MSN Lab's Nelarabine Injection
New Delhi: Highlighting the need for stronger post-marketing safety oversight, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), has directed MSN Laboratories Private Limited to revise and resubmit the Phase IV clinical trial protocol for Nelarabine Injection 250 mg/50 ml (5 mg/ml) within one month, before the study can proceed.
The committee reviewed the proposal in line with the conditions stipulated at the time of granting permission for the manufacture and marketing of Nelarabine Injection. As part of its post-marketing commitment, the firm presented a Phase IV clinical trial titled “A Phase IV, Open-label, Multicenter Study to Evaluate the Long-term Safety and Effectiveness of Nelarabine Injection 250 mg/50 mL (5 mg/mL) in Adult Patients with Relapsed or Refractory T-Acute Lymphoblastic Leukaemia (T-ALL) / Lymphoblastic Lymphoma (T-LBL)”.
The study was submitted vide Protocol No. 014/NLRN/MSN/2025, Version 1.0 dated 27 May 2025. After detailed deliberation, the SEC observed that certain critical aspects of the protocol required modification to ensure comprehensive safety evaluation and regulatory adequacy.
Accordingly, the committee recommended that the firm include the paediatric population in the proposed Phase IV clinical trial, noting the relevance of Nelarabine in both adult and paediatric T-cell malignancies. The SEC further directed the firm to clearly define the washout period between prior CAR-T cell therapy and treatment with Nelarabine Injection, considering the potential impact of previous advanced therapies on patient safety outcomes.
In addition, the committee advised the firm to revise the follow-up duration in the study, taking into account the median time interval for the occurrence of serious adverse events (SAEs) after the last dose of Nelarabine. These revisions were deemed necessary to strengthen the robustness of long-term safety and effectiveness data.
Based on these observations, the SEC instructed the firm to submit the revised Phase IV clinical trial protocol within one month for further review.
Nelarabine is a purine nucleoside analogue antineoplastic agent indicated for the treatment of relapsed or refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma, particularly in patients with limited therapeutic options.
MSN Laboratories Private Limited is engaged in the development and manufacture of complex injectable and oncology formulations, with ongoing regulatory-driven clinical research to support post-approval requirements.
