Regulatory milestones for Clovis Oncology's rociletinib

US personalized cancer therapy specialist Clovis Oncology (Nasdaq: CLVS) yesterday announced two major regulatory milestones for rociletinib, with the news pushing the firm’s shares up 4.1% to $89.03 in after-hours trading.

The US Food and Drug Administration has accepted Clovis’ New Drug Application for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016. The compound is its investigational therapy 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.

Additionally, the European Medicines Agency has accepted the Marketing Authorization Application for rociletinib. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted Clovis an accelerated assessment for the drug, which reduces the time limit for CHMP to reach an opinion from 210 days to 150 days. Accelerated assessment is granted in recognition of the likelihood that a therapeutic will be of major public health interest in the European Union, given the importance of therapeutic innovation in a patient population that exhibits a high unmet need.