- Drugmaker to submit information to regulators by Monday
- Rival AstraZeneca gains; treatment was approved last week
Clovis Oncology Inc. may have to wait longer for U.S. regulatory approval of its lung cancer drug rociletinib after the Food and Drug Administration requested more clinical information on the treatment. The shares plummeted.
The company plans to provide the data from its human trials of the drug by the close of business Monday, according to a statement. Clovis’s initial application for approval included early data on the effectiveness of the drug, including some patients who had an unconfirmed response to the treatment. In follow-up testing, a lower number of patients than expected had their response confirmed, Clovis said.
Clovis shares dropped 73 percent to $27.24 at 9:41 a.m. in New York, wiping out more than two years’ worth of gains.
As of June 30, Clovis was the biggest holding of Partner Fund Management, the drugmaker’s second-biggest shareholder with a 7.1 percent stake, according to data compiled by Bloomberg. It was also the second-biggest holding of Palo Alto Investors, with a 6.3 percent stake. Clovis’s top shareholder is Fidelity Investments, through its collection of funds.
The delay gives a boost to Clovis rival AstraZeneca Plc, whose lung cancer pill Tagrisso was approved early by the FDA last week. AstraZeneca shares rose 3.6 percent to 4,242 pence in London.
In an analysis of 79 patients on a 500-milligram dose of rociletinib, 28 percent have a confirmed response to the drug, Clovis said. A separate group of 170 patients on a 625-milligram dose has a 34 percent response rate. The duration of responses at both doses is "encouraging," the company said.