Early Clovis approval notches up competition in ovarian cancer

The FDA has approved Clovis Oncology’s rucaparib ovarian cancer drug, about two months ahead of schedule.

Sold under the brand name Rubraca, the drug is approved as a treatment for women with ovarian cancer who have been treated with two or more chemotherapies, and whose tumours test positive for the BRCA gene mutation.

Aalysts predict the drug faces stiff competition from AstraZeneca’s already-approved Lynparza (olaparib) and Tesaro’s niraparib, currently being reviewed by the FDA.

Rubraca has the advantage of slightly broader label than AZ’s drug, which generated sales of $58 million in Q3.

Clovis said the drug will be launched in the US immediately, and analysts believe the drug could achieve $1.5 billion in annual sales by 2020, if it can add additional indications such as fallopian tube and peritoneal cancer.

Despite the positive news, analysts still believe that Clovis’ drug is likely to end up in third place once all drugs are on the market.

Tesaro’s niraparib is currently under regulatory review in an earlier line of therapy (2L+ maintenance) for ovarian cancer with a launch expected in the first half of 2017.

Link up with Foundation Medicine

The BRCA mutation must be identified using an FDA-approved companion diagnostic test – and Clovis has already partnered with Foundation Medicine, which has developed the test to select patients with somatic or germline BRCA1 and BRCA2 mutations.

However this is an accelerated approval, based on mid-stage data objective response rate and duration of response data from the ARIEL 2 clinical trial and Study 10. The FDA had earmarked Rubraca as a Breakthrough Therapy and granted it a faster six-month Priority Review.

Clovis must submit data from ongoing later stage studies to ensure continued approval.

Like its rivals, Rubraca is a poly ADP ribose polymerase (PARP) inhibitor. The approval is a huge victory for Clovis, being its first ever approved drug. Rubraca was also the only drug left in Clovis’ pipeline, after it abandoned its lung cancer PARP inhibitor, rociletinib, on safety grounds earlier this year.

Now Clovis could decide to grow its pipeline through acquisition of an additional compound.

But Rubraca could soon be overshadowed by Tesaro’s niraparib, which was a highlight at the European Society for Medical Oncology conference in October.

Data presented at ESMO suggested niraparib could be used in a broad population of platinum-sensitive ovarian cancer patients, who have either germline mutation in the BRCA gene, or a tumour with high-grade serious histology.

Niraparib and AZ’s Lynparza could beat Rubraca to approval as maintenance therapies, and AbbVie and Pfizer’s latest acquisition, Medivation, have PARP inhibitors in development.

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