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.
