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 FDA in May 2014. Clovis agreed with FDA that the submission would be a rolling NDA and has filed the first component for potential accelerated approval of rociletinib in the US.
The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. The Company intends to complete the NDA submission by late July 2015.
"The initiation of this rolling submission represents a very important first step toward our biggest milestone of 2015 – the submission of our first NDA for rociletinib as treatment for patients with T790M-positive EGFR-mutant non-small cell lung cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
"We look forward to completing the NDA by the end of July, and are actively preparing for our first commercial launch."
In addition, the Company intends to complete the Marketing Authorization Application (MAA) for rociletinib to the European Medicines Agency at the end of July.
Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses.
Accordingly, it has the potential to treat NSCLC patients with EGFR mutations both as a first-line or second-line treatment with a potentially reduced toxicity profile. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.