CDSCO Panel grants Pfizer's Protocol Amendment for Anti-cancer Drug Palbociclib study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-16T16:45:48+05:30 | Updated On 21 March 2024 9:02 PM IST

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Pfizer's protocol amendment proposal for the the clinical trial titled " Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors".

This came after the drug maker Pfizer presented protocol amendment 7.0 dated 31 May 2023 protocol No. A5481092.

The above study aims to learn about safety and find out a maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents, and young adults with recurrent or refractory solid tumors.

Palbociclib 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. This helps stop or slow the spread of cancer cells.

Palbociclib is used in combination with another medication as an initial treatment for a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) that has spread to other parts of the body.

Palbociclib is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) that has spread to other parts of the body in people who have been treated successfully with an antiestrogen medication such as tamoxifen (Soltamox).

At the recent SEC meeting for Oncology held on 21st February 2024, the expert panel reviewed the proposal presented by the drug major Pfizer for protocol amendment 7.0 dated 31 May 2023 protocol No. A5481092.

After detailed deliberation, the committee approved the protocol amendment as presented by the firm.

Also Read: Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan

cdscopfizerpalbociclibsolid tumorschemotherapyprotocol amendment

Dr. Divya Colin

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

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