- Clovis Oncology will shut down patient enrollment in all clinical trials of its lung cancer drug rociletinib, nearly a month after a FDA panel overwhelmingly voted against recommending approval.
- In its first quarter report, Clovis said it expects a complete response letter from the FDA rejecting the drug sometime before June 28. As a result, the company will cut 35% of its staff by the end of 2016.
- Before running into regulatory troubles, rociletinib had been seen as a potential competitor for AstraZeneca’s Targrisso, a similar drug already approved by the FDA.
In addition to halting clinical enrollment for rociletinib, Clovis will also withdraw its previously filed application with the European Medicines Agency, closing the door on the drug in both markets.
The FDA advisory committee in April had questioned the reliance on unconfirmed responses in the drug’s efficacy data and highlighted several safety concerns. In a 12-1 vote, the panel recommended the FDA wait until the drug’s phase 3 study wrapped up before considering the drug for approval.
But Clovis appears to have decided to move on entirely with its decision to halt clinical enrollment. The focus now sifts to rucaparib, an orally active PARP drug in development for treatment of BRCA-mutated breast cancer.
Clovis has already filed the first component of its rolling new drug application with the FDA and expects to complete it by the end of the second quarter.
In addition, Clovis is partnering with Genentech to test rucaparib in combination with Genentech’s much-anticipated atezolizumab against gynecological cancers.
With $445.5 million in cash on hand, Clovis said it can fund operations through 2018. But losing rociletinib is a blow. The company had hoped to gain accelerated approval, which would have allowed the drug to be marketed while further studies continued. That would have given Clovis some positive cash flow to offset its steady quarterly losses and help fund development costs for rucaparib.