Eli Lilly Gets CDSCO Panel Nod To import, and market anticancer Selpercatinib Tablets
New Delhi: Pharmaceutical major Eli Lilly has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market the anti-cancer drug Selpercatinib Tablets 40mg, 80mg, 120mg and 160mg for proposed strength and indication with the condition to conduct Phase IV clinical trials.
This came drug maker Eli Lilly presented the proposal for grant of permission to import and marketing of the drug Selpercatinib Tablets 40mg, 80mg, 120mg and 160mg for additional indication, additional strength and new dosage form along with Global bioequivalence (BE) study (J2G-MC-JZJZ) for 160 mg tablet, food effect study (J2G-MC-JZPA) results (Global study where Indian patients did not participate) and ongoing Phase III study LIBRETTO-531 (05 Indian patients participating) before the committee
The committee noted that CDSCO has already approved Selpercatinib Capsules 40 mg and 80 mg. The committee also noted that selpercatinib, an orphan drug, is approved in key countries, i.e. US, the EU, the UK, Canada, Australia, etc.
Selpercatinib is used to treat locally advanced or metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors have RET fusion-positive genes. Your doctor will perform a test to check for the RET gene fusion before you use this medicine.
At the recent SEC meeting for Oncology held on 2nd April 2025, the expert panel reviewed the proposal for grant of permission to import and market the drug Selpercatinib Tablets 40mg, 80mg, 120mg and 160mg for additional indication, additional strength and new dosage form along with the Global BE study (J2G-MC-JZJZ) for the 160 mg tablet, the food effect study (J2G-MC-JZPA) results (a global study where Indian patients did not participated) and the ongoing Phase III study LIBRETTO-531 (5 Indian patients participating).
After detailed deliberation, the committee recommended the import and marketing of Selpercatinib Tablets 40mg, 80mg, 120mg and 160mg for proposed strength and indication with the condition to conduct a Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV Protocol to CDSCO within 03 months of approval for review by the committee.
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