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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.
Also Read: Pfizer Gets CDSCO Panel Nod to Study Anti-cancer Drug PF-07220060
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.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751