FDA to evaluate cancer therapies in patients with brain metastases

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System MetastasesExternal Link Disclaimer,” which, if finalized, would provide recommendations to sponsors designing clinical trials of drugs and biological products that are intended to support product labeling describing anti-tumor (preventing or inhibiting the formation or growth of tumors) activity in patients with central nervous system metastases from solid tumors originating outside the CNS.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Table of Contents

YOU MAY BE INTERESTED IN

The long-awaited results from the RASolute 302 trial—a phase III clinical trial evaluating daraxonrasib, a RAS inhibitor, for the treatment of patients with previously treated, metastatic pancreatic ductal adenocarcinoma—have been read out. 
At a lecture at Yale Cancer Center recently, Robert A. Winn brandished a copy of a 32-year old booklet titled “Cancer at a Crossroads: A Report to Congress for the Nation,” using it as a show-and-tell prop in arguing that America’s cancer program is once again at a crossroads and therefore in urgent need of strategic thinking (The Cancer Letter, April 10, 2026).

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login