Yesterday was the official PDUFA date for Clovis Oncology’s rociletinib. But the company — now maintaining very low visibility — let it slide past without formally announcing a rejection that had already been flagged from an earlier communication with the agency.
Clovis’ shares ($CLVS), though, jumped 20% this morning. Why?
That has to do with the spike in Tesaro’s shares ($TSRO), which soared in the wake of progression-free-survival among patients taking niraparib, its PARP inhibitor. Clovis has a late-stage PARP inhibitor, rucaparib, and Tesaro’s win helped boost the Boulder, CO-based biotech’s battered stock.
Clovis reported weeks ago that regulators had wasted little time informing Clovis that a CRL was on the way by the June 28 PDUFA date for roci. The agency’s position on the drug was clear at its expert panel review: The company had been caught playing fast and loose with “complete” response rates, and the final data that Clovis had submitted made it clear that there were better drugs to pick from — including AstraZeneca’s newly approved Tagrisso.
There was a unanimous ‘no’ vote and FDA cancer czar Richard Pazdur – not known for cutting shifty data any slack, remember Aveo? – quickly sealed the deal.
Clovis once was considered a direct contender for the non-small cell lung cancer market, punching back at AstraZeneca with a series of data releases that made it look like its approval would be a virtual certainty. Big things were expected commercially.
Instead, it became Clovis’s latest in a series of debacles. And it forced the biotech to restructure as the feds launched a probe into the way the company and CEO Patrick Mahaffy had conducted itself, according to SEC filings.
The next chapter at Clovis now focuses on rucaparib, one of several contenders for top PARP inhibitor. Even as CEO Patrick Mahaffy hacked a large part of Clovis’ staff, he highlighted that he would keep a commercial team together as the biotech prepped its “rolling submission” for rucaparib.
Rucaparib is facing off against a wave of PARP inhibitors in the pipeline. Sanofi is making a bid for Medivation in part because of its late-stage PARP inhibitor, talazoparib. And AstraZeneca beat it to the market with their approval for olaparib. AbbVie is also in the hunt.
So June 29 helped spotlight Clovis in a favorable light. Even if it still hasn’t posted the final death notice on roci.
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