The U.S. Food and Drug Administration granted priority review to Clovis Oncology Inc.'s application seeking expanded use of Rubraca to treat certain patients with a type of prostate cancer.
Rubraca, or rucaparib, was approved in the U.S. in 2016 to treat certain patients with ovarian, fallopian tube and primary peritoneal cancers. The company is now pursuing approval for the therapy as a standalone treatment for adult patients with castrate-resistant prostate cancer that comes back and has spread to other parts of the body. These patients should also have a mutation in their BRCA1 and BRCA2 genes.
The Boulder, Colo.-based biopharmaceutical company said the FDA is expected to make a decision around May 15 due to the priority designation, which cuts down the review period to six months from the standard 10 months. The supplemental new drug application, which was submitted in November 2019, is backed by data from a clinical program called Triton.
Rubraca received the FDA's breakthrough therapy designation in October 2018 for this particular patient population in prostate cancer and was also approved by the U.K.'s National Institute for Health and Care Excellence in October 2019 to treat women with ovarian cancer.