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FDA has issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System MetastasesExternal Link Disclaimer,” which, if finalized, would provide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

If you listen to GRAIL executives discuss the results of the long-awaited trial of the company’s multicancer detection test, you might be led to conclude that the company’s pivotal NHS-Galleri study had an overwhelmingly positive result.
Undeterred by the negative topline result of its pivotal trial of Galleri, a multicancer detection test, the test’s sponsor, GRAIL, said it’s forging ahead with its plan to get FDA approval and reimbursement from CMS and private insurers.
Philip E. Castle, director of the NCI Division of Cancer Prevention, said he was disappointed to hear that GRAIL’s NHS-Galleri trial did not meet its primary endpoint of reduction in late-stage cancers.

Never miss an issue!

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

Login