Eli Lilly Gets CDSCO Panel Nod To Import, Market Anti-cancer Drug Selpercatinib

New Delhi: Advising to conduct the Phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the pharmaceutical major Eli Lilly to import and market the anti-cancer drug Selpercatinib 40 mg and 80 mg.

The expert panel recommended the grant of permission to import and market Selpercatinib Capsule 40mg and 80mg for the indication:

 Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

 Adult and pediatric patients 12 years of age and older with advanced or metastatic RETmutant medullary thyroid cancer (MTC) who require systemic therapy.

 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate).

This came after the drug major Eli Lilly presented its proposal for a grant of permission to import and market Selpercatinib Capsule 40mg and 80mg along with the Phase IV clinical trial waiver before the committee.

Selpercatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. 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.

The mechanism of action of selpercatinib is as a Rearranged during Transfection (RET) Inhibitor, Cytochrome P450 2C8 Inhibitor, and Cytochrome P450 3A Inhibitor, and P-Glycoprotein Inhibitor, and Breast Cancer Resistance Protein Inhibitor, and Multidrug and Toxin Extrusion Transporter 1 Inhibitor.

At the recent SEC meeting for Oncology held on 19th and 20th March 2024, the expert panel reviewed the proposal presented by the drug major Eli Lilly for the grant of permission to import and market Selpercatinib Capsule 40mg & 80mg along with the Phase IV clinical trial waiver.

After detailed deliberation, the committee recommended granting permission to import and market Selpercatinib Capsule 40mg & 80mg for the indication:

 Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.

 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

However, the committee did not recommend the Phase IV clinical trial waiver.

Accordingly, the expert panel suggested that the firm should submit the Phase IV Clinical Trial protocol within 3 months of approval for further consideration by the committee.

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