FDA approves Clovis’ flagship drug for prostate cancer treatment
BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) received approval from federal drug regulators to sell its Rubraca treatment for use in prostate-cancer patients.
The Boulder pharmaceutical company said the drug will be available to prostate cancer patients who haven’t responded to chemotherapy or other existing forms of treatment. The drug was given priority review status in January for an Phase III trial in patients.
“We are pleased that the FDA has granted an accelerated approval for Rubraca in this third indication,” CEO Patrick Mahaffy said in a statement.
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Rubraca, which was originally approved for use in 2016 for treating advanced ovarian cancer, is the only product Clovis has greenlit for sale. The company sold $143 million worth of Rubraca in 2019, a $47 million increase from the previous year.