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Clovis Oncology Starts Rolling NDA Submission for Rociletinib - Analyst Blog

Clovis Oncology, Inc. CLVS has initiated the submission of a rolling New Drug Application to the FDA for rociletinib. The company is looking to get rociletinib approved for the treatment of patients with non small cell lung cancer (NSCLC) with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

The company expects to finish submitting the rolling NDA by the end of July. The company also expects to submit its EU regulatory application by the end of July. Rociletinib has Breakthrough Therapy designation in the U.S.

In May 2015, Clovis had provided updated data from the TIGER-X phase II study on rociletinib (CO-1686). A 60% overall response rate (ORR) and 90% disease control rate (DCR) was observed in heavily pretreated centrally confirmed tissue T790M-positive patients. Median progression free survival (PFS) was 10.3 months in patients without a history of CNS metastases while it was 8 months in the overall population of 270 heavily pretreated centrally confirmed tissue T790M- positive patients, including 40% of patients with a history of CNS metastases.

The candidate was found to be well-tolerated with hyperglycemia being the only common grade 3 treatment-related adverse event to be observed.

Meanwhile, Clovis expects to initiate a phase II study on rociletinib in Japan in the second half of 2015. It also plans to initiate multiple combination studies in the second half of 2015.

Besides rociletinib, Clovis has another promising candidate in its pipeline - rucaparib which is being developed to treat patients with advanced ovarian cancer.

Clovis currently carries a Zacks Rank #3 (Hold). INSYS Therapeutics, Inc INSY, Achillion Pharmaceuticals, Inc. ACHN and China Biologic Products, Inc. CBPO are better-ranked stocks in the health care sector, each carrying a Zacks Rank #1 (Strong Buy).

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