AbbVie’s sNDA accepted for priority review for Imbruvica in combination with Gazyva for previously untreated CLL

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

AbbVie said FDA has accepted its supplemental New Drug Application for Priority Review for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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