Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients

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

FDA approved the Ventana ALK CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib).

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

YOU MAY BE INTERESTED IN

Recently, HHS Secretary Robert F. Kennedy Jr. posted a video montage featuring himself shirtless in jeans, working out with Kid Rock. The duo is in a blue-lit grotto with a cold plunge and sauna. Set to Kid Rock’s “Bawitdaba” and intercut with a selection of patriotic imagery, the video ends with the two men in a hot tub, chugging what appears to be milk.
In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies. 

Never miss an issue!

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

Login