FDA officials said drug sponsors will soon be required to conduct randomized studies to determine optimal dosages of cancer drugs before proceeding to testing safety and efficacy in pivotal trials.
“We are going to start making this a requirement”, stated Richard Pazdur, MD during STAT’s ASCO Recap on June 9, 2021.
In a three-day meeting this week, the FDA Oncologic Drugs Advisory Committee will be asked to determine viability of six indications for drugs that target PD-/PD-L1 proteins.
The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.
