FDA last week issued a draft guidance that urges sponsors to conduct randomized controlled trials when they seek accelerated approval.
The FDA Oncologic Drugs Advisory Committee March 9 voted 11:2 in favor the approval of Polivy (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treatment-naive diffuse large B-cell lymphoma.
Can a single drug replace a long-established curative, albeit brutal, regimen of chemotherapy, radiation, and surgery?
FDA has been mulling over reliance on real-world evidence for about a decade, keeping it on the edges of the existing approval system that runs on data from conventional clinical trials.
Getting the dose right is not a mere formality but a fundamentally important first step that can mean the difference between success and failure of a drug development program, Richard Pazdur, director of the FDA Oncology Center of Excellence, said at a workshop focused on the issue of dose optimization.
As more targeted cancer therapies hit the market, the maximum tolerated dose approach to cancer drug development no longer makes sense, said Brian Booth, director of FDA’s Division of Cancer Pharmacology I, at the April 21 meeting of the FDA Oncologic Drugs Advisory Committee.
FDA has announced proposed product standards that would prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors other than tobacco in cigars.
In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population
The FDA Oncologic Drugs Advisory Committee expressed decisive support for the agency’s view that data from trials of checkpoint inhibitors performed in mainland China aren’t applicable to the U.S. population.
FDA is preparing to review an estimated 25 applications for cancer drugs that are being developed based largely—and in many cases entirely—on data from mainland China.
Here is an update on the FDA effort to cull the backlog of what the agency has colorfully dubbed the “dangling indications” of cancer drugs: two indications taken off the market by sponsors; one facing an uncertain future.
