Submit Justification and Rational: CDSCO Panel tells Pfizer on protocol amendment proposal for Palbociclib
New Delhi: In response to the proposal presented by the drug major Pfizer for the protocol amendment, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the justification and rationale for the proposed amendment of the anti-cancer drug Palbociclib.
This came after the firm presented Protocol Amendment 7.0 dated 31 May 2023, Protocol no. A5481092.
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 an oral medicine that is used to treat specific types of breast cancer in adults. It is used in combination with other cancer treatments, either aromatase inhibitor or fulvestrant depending on clinical factors.
At the recent SEC meeting for Oncology and Hematology held on the 29th and 30th of November 2023, the expert panel reviewed the proposal presented by the drug major Pfizer for the protocol Amendment of the anti-cancer drug (Palbociclib).
After detailed deliberation, the committee recommended that the justification and rationale for the proposed amendment need to be submitted for further review by the committee.
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