Clovis Oncology (CLVS) Announces Submission of Rociletinib NDA to U.S. FDA for EGFR NSCLC

August 3, 2015 6:07 AM EDT

Clovis Oncology (NASDAQ: CLVS) announced that it has submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. Rociletinib is the Company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

In addition, Clovis has also 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.

There is a validation period before both applications are formally accepted, after which the review commences.

“The submissions of our first NDA and MAA for rociletinib represent a major step forward for our company,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “These two submissions – completed on the same day, no less -- were made possible through the tremendous commitment and hard work of Clovis employees and our clinical collaborators at leading U.S. and international academic institutions over the last many months, and I am grateful for their tireless efforts. We are actively preparing for what we hope to be our first U.S. commercial launch, and the opportunity to address the needs of patients with T790M-positive EGFR-mutant non-small cell lung cancer. We are also actively building our commercial organization in Europe to prepare for a potential launch next year.”

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. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of QIAGEN’s QIAsymphony family of laboratory solutions.

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