An FDA advisory panel dealt a potentially punishing blow to Boulder-based Clovis Oncology’s late-stage lung cancer drug.
The Oncologic Drugs Advisory Committee, an independent panel of the U.S. Food and Drug Administration, on Tuesday recommended in a 12-1 vote that the FDA not give fast approval to Clovis’ rociletinib until additional results are available from TIGER-3, an ongoing Phase 3 trial.
The FDA was expected to decide on an accelerated approval for rociletinib by June 28. TIGER-3’s patient enrollment is expected to be complete in late 2018.
“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 J. Mahaffy said in a statement. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”
Following a trading halt issued in advance of pending material news, Clovis shares closed down 5.4 percent at $14.24.
Clovis officials declined to comment further.
Rociletinib, a targeted oral tablet for non-small-cell lung cancer, has faced significant hurdles on its path toward commercialization.
In November, just days after , the FDA sought additional information about rociletinib, lengthening the review process by months. , plunging 70 percent to $30.24.
On Friday, a briefing from the FDA staff noted that 47 percent of patients had serious adverse reactions, including abnormal — and potentially fatal — heart problems.
After that release, Clovis’ stock tumbled to its lowest level in three years. On Monday, Clovis shares dropped more than 5 percent to $15.06. Clovis’ 52-week high was $116.75.
FDA staff on Friday recommended the product carry a “black box warning” that the drug could lead to a condition known as Torsades de pointes, in which the heart can beat as fast as 250 beats per minute. FDA staff also recommended that patients receive ECG monitoring while on the drug.
The briefing materials raised questions about whether rociletinib would be eventually approved, Kennen MacKay, a Credit Suisse analyst who covers Clovis, wrote Friday in a research note.
“We view (Friday’s) FDA ODAC briefing documents as a negative for rociletinib’s potential FDA accelerated approval and ultimate commercial opportunity,” MacKay wrote.
The briefing documents also call into question the credibility of Clovis’ management, MacKay said, adding that Clovis executives did not relay information to analysts in February that the FDA did not support increasing the recommended dosage of rociletinib.
