FDA gives Clovis’ flagship drug priority review for prostate cancer trials

BOULDER — The U.S. Food and Drug Administration is fast-tracking clinical review for Clovis Oncology Inc. (Nasdaq: CLVS) as it tries to expand the reach of its flagship drug to treat other types of cancer.

The Boulder-based biopharmaceutical company said the FDA granted it priority review for its clinical trials for Rubraca as a standalone treatment for advanced forms of prostate cancer that show resistance to other therapies.

Federal regulators give priority review to drugs it believes could cure previously untreatable diseases or therapies thought to provide far better outcomes for patients than other treatments currently on the market. It cuts the administration’s 10-month review period to six months.

“This filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” CEO Patrick Mahaffy said in a prepared statement.

Rubraca is the company’s only drug approved for sale in the United States and European Union. It is primarily prescribed to ovarian-cancer patients and survivors to lower the chance of relapse, but is thought to help control solid-tumor forms of cancer linked to a specific mutation in a person’s genetics.

The drug is being tested in seven other clinical trials, three of which are in the third and final phase of study before federal regulators grant or deny their sale to patients.

The FDA’s nod improved investor outlook on Clovis, which looked extremely vulnerable to acquisition offers last August. Its share price fell almost 30 percent in a week due to far greater losses than analysts expected in the second quarter of 2019, and because it took out $225 million in new debt to refinance its existing debt and shore up the company’s operating cash flow.

The company sold $143 million worth of Rubraca in 2019, a $47 million increase from the previous year. However, that figure was dwarfed by Lynparza, a competing ovarian-cancer therapy backed by drugmaker giant AstraZeneca PLC (NYSE: AZN) that pulled in $520 million in sales in the first half of 2019 alone.

This story previously stated the FDA’s priority review would allow Clovis to start clinical trials. Priority review is meant to fast-track review of existing clinical data.

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