Eli Lilly Kinsale gets CDSCO panel nod to import, market anticancer drug Selpercatinib
New Delhi: Granting the clinical trial waiver, the Subject Expert Committee ( SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharmaceutical major, Eli Lilly Kinsale to import and marketing of anticancer drug Selpercatinib 40 mg and 80 mg capsules.
However, the approval is subject to condition that the firm should increase number of Indian subjects in ongoing global clinical trial in the country.
In addition, conditions also include that the firm should conduct Phase IV clinical trial in the country for which the protocol should be submitted to CDSCO within two months of approval of the drug for further review by the committee.
This came in line with the proposal presented by the drug maker Eli Lilly Kinsale for import and marketing of the drug Selpercatinib 40 mg and 80 mg capsules along with justification for 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. This helps slow or stop the spread of cancer cells.
Selpercatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that have spread to other parts of the body in adults. It is also used to treat a certain type of thyroid cancer in adults and children 12 years of age and older that has spread to other parts of the body.
Selpercatinib is also used to treat another type of thyroid cancer that has spread to other parts of the body in adults and children 12 years of age and older who have been treated unsuccessfully with radioactive iodine.
At the recent SEC meeting for Oncology and Hematology, the expert panel reviewed the proposal for the import and market of Selpercatinib 40 mg and 80 mg capsules in detail.
The committee noted that the drug is already approved in US, EU, Canada, Japan, United Kingdom etc., and the drug is indicated for a disease which is serious and life threatening disease and there is an unmet medical need in the country.
After detailed deliberation, the committee recommended for grant of permission to import and marketing of Selpercatinib 40 mg and 80 mg capsules subject to the following conditions:
1. The firm should increase the number of Indian subjects in an ongoing global clinical trial in the country.
2. The firm should conduct Phase IV clinical trial in the country for which the protocol should be submitted to CDSCO within two months of approval of the drug for further review by the committee.
