Will the requirement by the US FDA to simultaneously co-develop companion diagnostics (CDx) delay the approval of receptor tyrosine kinase (RTK) inhibitors for RTK-rearranged (ROS1-, RET-, AXL-, PDGFR-a-, NTRK1-) non-small cell lung cancer globally?

The discovery of anaplastic lymphoma kinase (ALK) rearrangement in non-small cell lung cancer (NSCLC) in 2007 and the approval of crizotinib for the treatment of advanced ALK-rearranged NSCLC in 2011 represents a landmark in the development of targeted oncology therapy. The approval of crizotinib wa...

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Bibliographic Details
Main Author: Sai-Hong Ignatius Ou
Format: Article
Language:English
Published: Frontiers Media S.A. 2014-04-01
Series:Frontiers in Oncology
Subjects:
Online Access:http://journal.frontiersin.org/Journal/10.3389/fonc.2014.00058/full