Clovis set to challenge AZ with early PARP approval Rubraca

FDA
Clovis Oncology won an FDA approval Monday for Rubraca, a PARP inhibitor for use in ovarian cancer.

Ready to challenge AstraZeneca’s Lynparza, Clovis Oncology won a quick FDA approval Monday for Rubraca, a PARP inhibitor that the company said it will market at a “competitive” price.

The FDA green-lighted Rubraca more than two months ahead of the Feb. 23 PDUFA date under its accelerated approval program, clearing the med for use by ovarian cancer patients who have the BRCA gene mutation and who’ve already had two or more chemotherapies.

Rubraca's list price will ring up at $6,870 for a 15-day supply of the med at both the 300 mg and 200 mg dosage strengths, CEO Patrick Mahaffy told investors on a Monday afternoon conference call, noting that the company took the med's clinical impact into account when making its pricing decision. The company is also rolling out a patient assistance program that will provide financial assistance "where needed."

The drug will challenge AstraZeneca’s Lynparza, approved in advanced ovarian cancer back in 2014. That med, green-lighted on the strength of a phase 2 trial, has performed well for AZ, and now, the British drugmaker will have to defend its market position. The company has already started to build its defense, in October rolling out strong progression-free survival data from a phase 3 study.

And despite the early approval, Clovis says it's already ready to go in the marketing department. The Boulder, CO-based-company's 85-person sales force "is actually calling on physicians today," CEO Patrick Mahaffy said on a Monday afternoon call with investors.

"We anticipate, extremely modest, but inital sales this year," he said, noting that the company would be shipping the product throughout this week and next.

Aside from AZ, AbbVie, Pfizer and Tesaro each have potential PARP challengers in their respective pipelines. Back in October, Tesaro’s candidate niraparib posted progression-free survival benefits larger than have ever been seen in recurrent ovarian cancer, upping pressure on the other players in a hot field.

Before his company's sale to Pfizer for $14 billion, Medivation CEO David Hung described his company’s candidate, talazoparib, as “best-in-class” PARP med. Then, when Tesaro rolled out its data, investors responded by sending Medivation’s shares north.

A companion diagnostic to test for the gene mutation also won the FDA’s blessing on Monday. The cancer drug’s approval is one in a “trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes,” the FDA’s Richard Pazdur said in a statement.

About 15% to 20% of ovarian cancer patients have the BRCA gene mutation, according to the FDA.

Editor's note: This story has been updated with comments from a company conference call.