Clovis Oncology ($CLVS), whose market value has plummeted by more than 80% over the past year, has secured a date with FDA advisers to make the case that its lung cancer treatment merits approval despite some disappointing data.
The Boulder, CO, company is slated to appear before the agency's oncology committee on April 12 in support of rociletinib, an oral therapy designed to treat patients with non-small cell lung cancer and mutations in their EGFR genes. The panel will issue a nonbinding recommendation to the FDA, which has promised to issue a final decision on rociletinib by June 28.
For years, Clovis and rociletinib seemed neck and neck with AstraZeneca ($AZN) and its AZD9291, a fellow EGFR inhibitor approved as Tagrisso in the fall. But Clovis' case began to unravel in November when the company revealed that the FDA wanted to see more data on the drug before completing its review, adding that, in rociletinib's updated results, "the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected."
The news nearly decimated Clovis' share price and spurred widespread analyst concerns that rociletinib may struggle to compete with Tagrisso, provided it can even win approval.
On the one hand, Richard Pazdur, head of the FDA's oncology division, has taken a fairly forgiving approach to new cancer drugs in recent years, signing off on approvals for the sickest of patients and tasking companies with gathering more data that might support wider indications. However, the Oncologic Drugs Advisory Committee has in the past taken applicants to task for middling survival data, with Pazdur famously scolding Aveo Oncology ($AVEO) in 2013 over the soon-to-be-rejected tivozanib.
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