Clovis lung-cancer drug suffers major setback before FDA advisory committee
BOULDER — Clovis Oncology Inc.’s share price continued its freefall on Tuesday after an advisory committee for the U.S. Food and Drug Administration recommended against accelerated approval of Clovis lung cancer drug rociletinib.
Boulder-based Clovis had been hoping to receive regulatory approval for the drug by this summer. If the FDA, which is scheduled to rule on rociletinib in June, goes along with the committee’s decision, the move could push back approval of rociletinib to 2019, if approval comes at all.
The FDA’s Oncologic Drugs Advisory Committee voted 12-1 to recommend the FDA wait for final results from an ongoing Phase 3 clinical trial of rociletinib in the treatment of non-small cell lung cancer. The trial, dubbed TIGER-3, isn’t expected to complete patient enrollment until late 2018.
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The FDA in May 2014 had granted rociletinib Breakthrough Therapy designation, a status intended to help expedite development and review of certain drugs. But in November, the FDA requested more clinical data on the drug in part because the number of study patients with unconfirmed responses to rociletinib who had converted to confirmed responses was lower than had been expected. That led to an extension of the FDA’s decision date on the drug from March 30 to June 28.
Then on Friday, the FDA posted briefing materials in advance of Tuesday’s ODAC meeting that raised questions about side effects and dosing of rociletinib, as well as whether the drug’s efficacy was better than treatments already available on the market.
“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” Clovis president and CEO Patrick Mahaffy said in a prepared statement. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”
The Nasdaq stock exchange temporarily halted trading of Clovis stock (Nasdaq: CLVS) on Tuesday while the ODAC met to discuss the company’s New Drug Application. When trading resumed, shares opened at $12.91 and sank to a new 52-week low of $12.25 before closing at $14.24, down more than 5 percent from Monday’s close.
Clovis’ stock price hit a 52-week high of $116.75 on Sept. 17 before plunging nearly 70 percent on Nov. 16 after the FDA’s request for more information. The company’s share price has continued a steady decline since.
Rociletinib is not the only Clovis drug to have been granted Breakthrough Therapy status. Early last year, the company received the same designation for rucaparib, which is currently in advanced clinical trials for the treatment of ovarian cancer.
