Active ingredient: rucaparib
Disease: ovarian cancer
Peak sales estimate: $750 million to $1 billion
Approved: Dec. 19
Company: Clovis Oncology
The Scoop: With an accelerated approval ahead of its February 2017 PDUFA date, Clovis Oncology’s Rubraca is set to launch and challenge AstraZeneca’s Lynparza. A PARP inhibitor, Rubraca won FDA approval as a third-line ovarian cancer treatment for patients who have the BRCA gene mutation. Clovis priced the drug at $6,870 for a 15-day supply and already has its 85-person sales force calling on docs, execs told investors during a conference call following the approval. About 15% to 20% of ovarian cancer patients have the BRCA gene mutation, according to the FDA; the agency approved a companion diagnostic to test for the mutation on the same day. Aside from AZ, AbbVie, Pfizer and Tesaro each have potential PARP challengers in their respective pipelines.