CDSCO panel seeks data for Eli Lilly's anticancer drug selpercatinib

Written by Dr. Divya Colin Published On 2023-02-21T18:00:35+05:30 | Updated On 21 Feb 2023 6:00 PM IST

CDSCO panel seeks data for Eli Lillys anticancer drug selpercatinib

New Delhi: In response to the drug major Eli Lilly's proposal to waive off Phase IV clinical trial in the country for the Selpercatinib 40 & 80mg capsules, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit the criteria of dose justification, comparative safety data for the Indian patients, and the Global study particularly ICH countries who participated in the study by including all adverse events (AEs) and serious adverse effects (SAEs).

In addition, the expert panel suggested the firm submit information regarding the reason why, out of 41 screened patients, only 07 were randomised and 32 were discontinued before randomization.

This came after the firm presented its proposal to waive off Phase IV clinical trial in the country, before the committee.

Selpercatinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed. Selpercatinib is used to treat locally advanced or metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumours have RET fusion-positive genes.

Selpercatinib (LOXO-292) is a targeted therapy that works by inhibiting the activity of abnormal RET (rearranged during transfection) proteins. The drug is an oral therapy that patients take as a pill. In the trial, more patients responded to the drug—that is, their tumours shrank—than has been seen with older drugs that inhibit RET.

At the recent SEC meeting for Oncology & Haematology held on 9th February 2023, the expert panel reviewed the proposal presented by the drug major Eli-Lilly for the waiver off Phase IV clinical trial in the country.

After detailed deliberation, the committee recommended that the firm should submit the following data:

1. The criteria of dose justification for Indian patients.

2. Comparative safety data of Indian and Global study particularly ICH countries who participated in the study by including all AEs and SAEs.

3. Reasons why out of 41 screened patients only 07 were randomized and 32 were discontinued before randomization.

Accordingly, the committee asked the firm to submit the above data to CDSCO for re-deliberation before the committee.

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selpercatinibEli Lillyanticancer drugcdscoeli lilly newsphase 4 trial

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.