- Clovis Oncology Inc. on Monday reported full-year sales of $55.5 million for its ovarian cancer drug Rubraca, noting that figure does not include $14 million in free drug product provided through a patient assistant program which accounted for a fifth of total commercial drug supply.
- One of three PARP inhibitors on the market, Rubraca has battled with AstraZeneca plc's first-comer Lynparza and with new-comer Zejula from Tesaro Inc. Lynparza, the market leader, brought in $297 million in sales in 2017. Zejula brought in $109 million in its first nine months on market.
- Approval of Rubraca is still pending in Europe. The company submitted an application to the European Medicines Agency in 2016 and got a positive recommendation from the Committee for Medicinal Products for Human Use earlier this month.
Rubraca (rucaparib) was the second PARP inhibitor to hit the market behind AstraZeneca's Lynparza (olaparib), winning approval in December 2016 as a third-line treatment for ovarian cancer patients who have a deleterious germline or somatic BRCA mutations.
Clovis has since struggled to keep up in the market, though, as other PARP inhibitors gained approvals as second-line maintenance therapy with no need for diagnostic testing.
"[M]aintenance treatment is rapidly becoming the standard of care for advanced ovarian cancer patients which limits the available patient population for third line treatment with the PARP inhibitor," said CEO Patrick Mahaffy on the Feb. 26 earnings call with analysts.
"In addition, it has become rapidly apparent that given the choice of treating all-comers or ordering a tissue-based diagnostic test to identify the 25% of patients [with a] mutant BRCA [gene], physicians clearly are taking advantage of this new opportunity to avoid the cost and delays, and at times, frustrations associated with diagnostic testing."
Rubraca is currently under review by the Food and Drug Administration for the maintenance setting and a decision is expected by its user fee action date of April 6. Evercore ISI analyst Steven Breazzano pointed out in a note to clients that most ovarian cancer PARP inhibitor approvals have come early.
While Rubraca is still under review for its initial indication in Europe, the company said it plans to submit a variation of its marketing authorization in order to gain approval for the second-line maintenance setting as well, which could come as soon as six months after the initial approval.
"Given this timing, we are actively building out our European commercial and medical affairs leadership teams; obviously the majority of planned European hires, including the sales forces will coincide with reimbursement approval in the individual countries," added Mahaffy.
"We also now of course, have our regulatory clinical safety, quality and supply chain teams in place at our Cambridge, U.K. office."
The company is also developing Rubraca for other indications, including prostate and bladder cancer. Major data from the prostate cancer studies will likely be presented in October at the European Society for Medical Oncology conference. The drug is also in development as a combination therapy with Bristol-Myers Squibb Company's PD-1 inhibitor Opdivo (nivolumab) for ovarian, breast and prostate cancers.
But competitors aren't sitting still. AstraZeneca recently got approval for Lynparza as a treatment for breast cancer, and Tesaro announced Tuesday morning that it is now testing Zejua (niraparib) in combination with Roche AG's Tecentriq (atezolizumab) for bladder cancer.