Shares of Boulder-based Clovis Oncology rose more than 7 percent in after-hours trading Monday, following news that the Food and Drug Administration had deemed its new oncology drug a “breakthrough therapy.”
Clovis said the FDA granted the designation for its investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer patients.
This means that the drug will be fast-tracked for approval by the agency, as it could be a big leap forward for treatment of the disease.
The company said it would expand its Phase 2 study of the drug, adding as many as 300 women with recurrent cancer, and will use the data from the trial as a basis for its planned New Drug Application in 2016.
In May, Clovis became the first Colorado company to have one of its treatments receive the breakthrough therapy designation: its CO-1686 drug used to treat advanced lung cancer.
The breakthrough therapy program is a provision of the 2012 FDA Safety and Innovation Act co-authored by U.S. Sen. Michael Bennet. On Monday, Bennet applauded the recent designation.
“We need to ensure that our regulatory system is keeping up with 21st-century science and technology and not preventing these drugs from getting to patients who need them,” Bennet wrote in a news release.
The shares, which hit a 52-week high in mid-March, climbed to $74.25 in after-hours trading.
