Emergent public-private partnerships (PPPs) have risen to the occasion to streamline and coordinate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. With these monumental efforts have come important public discussions about equitable access and representation in clinical trials (CTs).
FDA approved the anti-PD-1 therapy Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Mark McLaughlin—a researcher with the West Virginia University Cancer Institute and Modulation Therapeutics Inc.—and his colleagues have received FDA approval to begin human trials of a new drug called MTI-201, which treats uveal melanoma after the cancer has traveled to another part of the body.
FDA watchers and clinical trialists in oncology may want to pay close attention to the agency’s latest plans to increase representation of traditionally marginalized populations in drug development.
There’s a cultural perception in drug development that enrolling a diverse, heterogeneous patient cohort can be “risky” for detecting drug effects—a perception that needs to go away, said Lola Fashoyin-Aje, associate director of the Science & Policy Program to Address Disparities at the FDA’s Oncology Center of Excellence and a deputy division director in the agency’s Office of Oncologic Diseases.
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)
