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 clinical trial of the anti-cancer drug PF-07220060 100 mg Tablets.
However, this approval is subject to the condition that justification for the sample size in India compared to the global sample size shall be submitted to CDSCO.
This came after the drug maker Pfizer presented Phase III clinical trial study protocol No. C4391022 final protocol dated 30 Jun 2023. This is a study to learn about the study medicine called PF-07220060 in combination with fulvestrant in people with HR-positive, HER2-negative advanced or metastatic breast cancer who progressed after a prior line of treatment.
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body.
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 on 5th March 2024, the expert panel reviewed the Phase III clinical trial study protocol No. C4391022 final protocol dated 30 Jun 2023.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by a firm with the condition that justification for sample size in India compared to global sample size shall be submitted to CDSCO.
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