Clovis Oncology files rociletinib at EMA for the treatment of adult patients with mutant EGFR NSCLC with the EGFR T790M mutation.
Clovis has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of adult patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
Qiagen, Clovis� companion diagnostic partner, intends to file a supplemental PMA application of its approved therascreen EGFR test with the FDA to allow for regulatory approval of the companion diagnostic concurrent with rociletinib approval. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M.
Comment: Clovis submitted an NDA for rociletinib for the treatment of adult patients with mutant EGFR NSCLC on 3 July 2015.
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