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