BIO Comments on Pediatric Cancer Drug Docket

The Biotechnology Innovation Organization (BIO) says it agrees with FDA that the rarity of pediatric cancers may render investigations of multiple same-in-class products unfeasible. The comment is included in the trade association’s response to the agency’s pediatric oncology subcommittee of the Oncologic Drugs Advisory Committee’s consideration of FDA’s planned development of a conceptual framework that will inform decision making on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development.

“In general,” the response says, “BIO believes the construction of a conceptual framework to assist FDA’s regulatory decision making should avoid unduly burdening one sponsor more than its competitors, utilize scientific data (e.g., mechanistic, nonclinical, clinical, etc.) and have a patient-centric approach.”