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| Clovis Oncology CEO Patrick Mahaffy |
Clovis Oncology ($CLVS) has joined the small group of biotech companies to pick up the FDA's coveted breakthrough therapy designation, an honor the drug developer believes will light the way to an early approval for its lung cancer candidate.
Clovis' CO-1686, an EGFR blocker designed to treat a certain type of non-small cell lung cancer (NSCLC), is now promised a speedy review and easy access to regulators, under agency policy. The FDA based its decision on interim safety and efficacy results from Clovis' ongoing Phase I/II study, the company said, in which the oral drug has charted an impressive objective response rate in NSCLC patients with the T790M mutation. There are no approved treatments for that population, according to Clovis.
Now it's on Clovis to follow through on that promise. The company is slated to divulge more data from the breakthrough-supporting trial at the annual ASCO meeting in Chicago this month, and it's in the midst of enrolling two Phase II expansion studies that, if positive, will make the case for CO-1686's eventual approval, CEO Patrick Mahaffy said.
"This designation is well-timed for us, as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application by mid-2015," Mahaffy said in a statement.
Since its institution in 2012, the FDA's breakthrough tag has led to early approvals for companies including Roche ($RHHBY), Johnson & Johnson ($JNJ) and Gilead Sciences ($GILD). But, as Novartis ($NVS) found out with its now-rejected cardio drug serelaxin, a front-row seat with regulators doesn't guarantee they'll like what they see.
Clovis' shares jumped about 7% in premarket trading on the news, and the biotech has had an up-and-down year on Wall Street amid M&A rumors and speculation on trial data. Since shooting up 80% last summer at last year's ASCO, Clovis has endured a volatile 12 months, hitting a high of nearly $90 per share in March before bottoming out at $47.83 last month.
The biotech's pipeline includes the Phase II PARP inhibitor rucaparib and lucitanib, a midstage targeted cancer therapy for which Clovis is paying up to $420 million.
- read the statement