The U.S. Food and Drug Administration has granted a fast-tracked review of using a Clovis Oncology drug to treat a wider range of ovarian cancer patients.
The Boulder-based company (Nasdaq: CLVS) seeks approval to use its ovarian cancer drug, rucaparib, as a maintenance treatment in women “with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are platinum sensitive” and regardless of their genetic profile.
The FDA says it will make a decision by April 6, 2018, Clovis announced Tuesday.
Completing a review in five months is half the time a fast-tracked FDA review can take, an option regulators have when there’s a chance to speed a promising drug to patients.
Read more at the Denver Business Journal: http://bit.ly/2BCLqFZ