Pfizer Gets CDSCO Panel Nod to Study Anti-cancer Drug PF-07220060
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.
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