USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance

The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA) on finding the optimal dosage for cancer drugs could slow drug development. On the other hand, several stakeholders praised the guidance while asking for additional details such as how to factor in dosing for multi-drug treatments.

Earlier this year FDA published a draft guidance to help sponsors identify the optimal dosage for cancer drugs earlier in clinical development. The agency recommended a new approach for selecting such dosages for modern, targeted oncology drugs. (RELATED: FDA details approach for finding optimal dosages for new cancer drugsRegulatory Focus 17 January 2023)

FDA said that dose-finding trials for cytotoxic chemotherapy drugs have historically been designed to determine the maximum tolerated dose (MTD), the approach may not be suitable for modern oncology drugs such as kinase inhibitors and monoclonal antibodies. Instead, the agency proposes a number of recommendations in the draft guidance to help sponsors determine proper drug dosage sooner for such drugs…