Clovis Oncology has bagged FDA approval for its ovarian cancer drug Rubraca, the first direct competitor to AstraZeneca's Lynparza.
Rubraca (rucaparib) has been cleared two months earlier than expected, given the green light for use in women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumours test positive for a gene mutation (deleterious BRCA) using a companion diagnostic.
The PARP inhibitor has previously been awarded a breakthrough designation by the FDA and - given the high unmet medical need in ovarian cancer - analysts at Credit Suisse have predicted Rubraca could become a $1.5bn-plus product by 2020, assuming it also picks up approval in some follow-up solid tumour indications such as fallopian tube and peritoneal cancer.
The early approval gives Clovis a boost as it sets off in pursuit of Lynparza (olaparib), which became the first PARP inhibitor to be launched on its debut in late 2014. AZ's drug has been approved in around 30 countries to date and sales reached $158m in the first nine months of the year.
The FDA approval is also a welcome relief for Clovis and its shareholders. The company has been pummelled in recent months after an FDA advisory panel voted against a quick approval of its lung cancer candidate rociletinib, a decision that eventually prompted the company to drop the drug.
Rubraca could face competition from not only Lynparza but also from Tesaro's highly-anticipated PARP inhibitor niraparib, which is already under regulatory review for ovarian, fallopian tube and peritoneal cancer.
According to some analysts, niraparib could benefit from a broader label than both Lynparza and Rubraca as it might get a maintenance therapy indication in the US. Lynparza was turned down for maintenance use by an FDA advisory panel last year, and can be used for maintenance in the EU only in patients with a BRCA mutation.
In trials, niraparib was able to improve progression-free survival (PFS) in recurrent ovarian cancer regardless of the patients' BRCA status.
Credit Suisse puts Lynparza sales at $1.6bn in 2020, just ahead of Rubraca, with niraparib in third place with just over $1bn in sales in that year.