Drug Development

After an R&D odyssey filled with setbacks, Clovis wins an FDA OK for rucaparib

Richard Padzur, Oncology Center of Excellence, FDA

Richard Padzur, Oncology Center of Excellence, FDA

Clovis Oncology $CLVS won some redemption today, gaining an accelerated approval for its first drug and setting it on a short path to commercialization.

The FDA has approved its PARP inhibitor rucaparib, to be sold as Rubraca, to treat ovarian cancer cases with BRCA mutations. The drug is entering a market that will be sliced and diced by a variety of competitors. The FoundationFocus CDxBRCA companion diagnostic was also OK’d for use with Rubraca.

Just last October the Boulder, CO-based biotech’s stock tanked after analysts were unimpressed by the latest data cut, with median progression-free survival time in a single-arm study at ten months. That’s fine for an FDA approval in cancer, though, and Rubraca will now weigh in against AstraZeneca’s pioneering Lynparza, which may prove the favorite of the two.  There’s also an upcoming decision on Tesaro’s rival niraparib, though that is for a different initial patient population. Pfizer is coming up from behind with a PARP, talazoparib, that it acquired in the $14 billion Medivation buyout.

Leerink’s Seamus Fernandez noted:

While this current approval is unlikely to impact the initial competitive dynamics for TSRO’s (OP) niraparib or AZN’s (OP) Lynparza (olaparib) in 2L maintenance, data from Rubraca’s Phase 3 ARIEL3 trial in this setting are now expected in mid-2017 (vs. 2H:17 previously). Despite this earlier readout, we continue to see niraparib as the ultimate winner in 2L maintenance (approval likely in 1H:17), with its Phase 3 NOVA trial having already established a strong progression-free survival (PFS) benefit in a broad population.

Tesaro reported earlier that the niraparib arm hit the primary endpoint of their study with a median PFS of 12.9 months compared to 3.8 months for the control arm. Among germline BRCA mutation patients, the median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control.

It’s all good for Clovis today, though, which saw its shares surge an initial 15% after gaining an approval that followed multiple setbacks along the way. The biotech was forced to restate its data submitted for an approval of rociletinib, prompting an embarrassing and devastating drop in the number of responses that the biotech had claimed for their drug. An FDA panel subsequently rejected the drug, prompting Clovis to restructure and lay off staffers, while burying roci as a loser.

Clovis did not cut its commercial group, though, confident that it could finally score a win here.

“Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”

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