Pfizer Gets CDSCO Panel Nod To study anti-cancer drug Lorlatinib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Pfizer for conducting the clinical trial of the anti-cancer drug Lorlatinib.

This came after the drug maker Pfizer presented Phase IV clinical trial study protocol No. B7461039 amendment 1 dated 19.07.2022. The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention.

Lorlatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that has spread to other parts of the body. Lorlatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply.

Lorlatinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have a certain type of abnormal anaplastic lymphoma kinase (ALK) gene. Your doctor will perform a test to check for the ALK gene before you use this medicine.

At the recent SEC meeting for Oncology held on 5th March 2024, the expert panel reviewed the Phase IV clinical trial study protocol No. B7461039 amendment 1 dated 19.07.2022.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

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