Pfizer Gets CDSCO Panel Nod To Study Anti-cancer Drug PF-07220060
Pfizer
New Delhi: The drug major Pfizer has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical trial of the anti-cancer drug PF-07220060 100 mg immediate release (IR) tablets.
PF-07220060 is a first-in-class CDK4 selective inhibitor with superior efficacy and an improved safety profile when compared to dual CDK4/6 inhibitors. PF-07220060 is being evaluated in HR+, HER2- breast and prostate.
The approval is subject to the condition that the number of subjects shall be increased up to 100 and more government sites shall be included in the study.
This came after drug maker Pfizer presented phase 3 clinical study protocol no. C4391024 Final Protocol dated 03 September 2024.
PF-07220060 is a novel potent oral CDK4-selective inhibitor with significant sparing of CDK6. PF-07220060 is under development for the treatment of solid tumours including liposarcoma, prostate cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, HER2 positive breast cancer and HER2 negative breast cancer, colorectal cancer (CRC), and adenocarcinoma of non-small cell lung cancer (NSCLC). It is administered through the oral route. The drug candidate acts by targeting CDK4.
At the recent SEC meeting for oncology, the expert panel reviewed the phase 3 clinical study protocol no. C4391024 Final Protocol dated 03 September 2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with following conditions:
1. The number of subjects shall be increased up to 100.2. More government sites shall be included in the study.
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