Please login to the form below

Not currently logged in

Clovis leapfrogs PARP rivals, filing Rubraca for prostate cancer

If approved would become first targeted therapy for tumour type

Clovis Oncology

Clovis Oncology’s Rubraca has been something of an also-ran among PARP inhibitors when it comes to market share, but a first-in-class filing in prostate cancer could give the product a boost.

The FDA has just started a six-month priority review of Rubraca (rucaparib), with a verdict due by 15 May, as a monotherapy for adults with BRCA1/2-mutated recurrent, metastatic castrate-resistant prostate cancer (CRPC). Mutations in the BRCA1/2 genes are the most common defects in patients with mCRPC.

Clovis is seeking approval for Rubraca in patients who have received a prior round of taxane-based chemotherapy, as well as at least one of the newer hormonal agents, such as Johnson & Johnson’s Zytiga (abiraterone) or Pfizer’s Xtandi (enzalutamide).

It’s currently used as a maintenance treatment for ovarian, fallopian tube and primary peritoneal cancer after chemotherapy, and as a third-line or later therapy for relapsed patients with BRCA mutations in these cancers.

If approved in prostate cancer, Rubraca would be the first targeted therapy for this type of solid tumour.

The filing means that Rubraca has beaten rivals such as AstraZeneca/Merck & Co’s market-leading Lynparza (olaparib), GlaxoSmithKline/Janssen’s Zejula (niraparib) and Pfizer’s new entrant Talzenna (talazoparib) to the punch in prostate cancer, a potentially lucrative new indication for the PARP class.

First approval could give Clovis an opportunity to build familiarity with its brand among clinicians treating CRPC before its big pharma rivals reach the market, although its rivals are hot on its heels.

AZ and Merck already have a successful phase 3 trial in hand for Lynparza in second-line CRPC and have said they plan to file for approval in this indication in the first half of 2020, while GSK/J&J have also reported positive pivotal data for Zejula in CRPC and are thought to be also planning regulatory submissions this year.

J&J has exclusive rights to Zejula in prostate cancer under the terms of an agreement signed with the drug’s develop Tesaro ahead of its $5.1bn acquisition by GSK last year.

All three of the PARP inhibitors have been awarded a breakthrough designation from the FDA in prostate cancer, reflecting the urgent need for new therapies to treat the disease.

Clovis’ marketing application is based on the results from the TRITON trials programme, in particular the TRITON2 study which showed a 44% response rate with Rubraca in BRCA-mutated CRPC, and a 52% prostate-specific antigen (PSA) response.

A combination trial of Rubraca plus Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) – called CheckMate 9KD – is also ongoing with initial results due later this year.

Article by
Phil Taylor

16th January 2020

From: Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company
Four Health

Beautiful things happen when you put the right ingredients together. It’s the reason that we mix behaviour change experts with...

Latest intelligence

Data desires
What are you looking to achieve with data and how are you preparing yourself to react to the results?...
The balancing act that’s keeping pharma and biotech market access on its toes
Pricing drugs and gaining reimbursement can be a real challenge for drug developers. Price it too high, and no one buys it. Price it too low, and it’s hard to...
Tackling antimicrobial resistance on multiple fronts
An urgent change of direction is needed in how we respond to AMR...