The FDA has promised a quick review for Clovis Oncology's ($CLVS) new lung cancer treatment, bolstering the company's prospects as it races against a similar drug from AstraZeneca ($AZN).
Clovis' rociletinib, formerly CO-1686, is in line for a final FDA decision by March 30, the company said, after the agency cut short the standard 10-month process by granting its priority review designation. Meanwhile, the European Medicines Agency accepted rociletinib's application and put the drug in its accelerated assessment program, putting Clovis in line for a committee opinion within 150 days instead of the usual 210.
Each distinction will come in handy as Clovis prepares for a potential market clash with AstraZeneca's AZD9291, a fellow treatment for non-small cell lung cancer that has charted a similar clinical profile to rociletinib. AstraZeneca submitted its drug earlier this year and has also been granted a priority review, but the U.K. drugmaker has not disclosed the agency's expected decision date.
The two treatments target lung cancer patients already who have already received first-line therapy and whose EGFR genes carry a mutation called T790M. In pivotal trials, each has increased progression-free survival by at least 8 months, helping both drugs secure the FDA's coveted breakthrough-therapy designation.
Clovis is also on a collision course with AstraZeneca in ovarian cancer, advancing drugs that work by inhibiting enzymes called poly ADP ribose polymerases, or PARPs. In April, the FDA gave Clovis' rucaparib a breakthrough tag for use against advanced ovarian cancer in patients with BRCA mutations who have failed two lines of therapy, whereas AstraZeneca tried and failed to secure the same designation for its similar treatment, approved as Lynparza late last year.
Clovis' recent run of form has helped stoke persistent buyout rumors, which have ebbed and flowed for years as the company has advanced its cancer pipeline through midstage development.
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