Drug manufacturers and researchers have a moral obligation to design clinical trials that adequately represent the target population for the investigational agent—and these medical products need to be safe and effective for everyone, leading clinical trial experts in oncology say.
FDA officials said the questions about accelerated approval of PD-1 and PD-L1 drugs have been largely resolved, thanks in part to guidance from the Oncologic Drugs Advisory Committee.
In health, the immune system plays a key role in protecting us not only from infectious disease, but also from the development of cancer; immune cells recognize and destroy harmful agents, whether pathogens or malignant cells.
The FDA Oncologic Drugs Advisory Committee, in an 13-4 vote, recommended against approval of retifanlimab, a PD-1 inhibitor, for the treatment of squamous carcinoma of the anal canal.
In March 2010, as part of Affordable Care Act, Congress passed a well-conceived and critical legislative bill, the Biologic Pricing and Competition Innovation Act of 2009 (BPCIA)
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.
