Clovis Oncology submits New Drug Application for cancer drug rociletinib

BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) announced Monday that it has submitted a New Drug Application with the U.S. Food and Drug Administration for cancer-drug candidate rociletinib.

In addition, the Boulder-based company has also submitted a Marketing Authorization Application to the European Medicines Agency for commercialization of the drug in Europe.

If attained, the approvals would allow Clovis to market rociletinib for the treatment of mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) in patients who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. NSCLC accounts for about 85 percent of all lung cancers, with EFGR mutations occurring in about 10 to 15 percent of NSCLC cases in Caucasian patients and about 30 percent to 35 percent of East Asian patients, according to a Clovis statement.

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Rociletinib was granted breakthrough therapy designation by the FDA last year, and would be the company’s first drug to reach commercialization if approvals are granted. The company last month completed a follow-on stock offering that raised nearly $300 million in net proceeds, much of which will go toward commercialization efforts of rociletinib and rucaparib.

Clovis shares climbed $1.29 to close at $85.72 on Monday.

“The submissions of our first NDA and MAA for rociletinib represent a major step forward for our company,” Clovis CEO Patrick Mahaffy said in a prepared statement. “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.”