FDA Delays OK on New Use for Genentech Drug
Genentech Inc. said Monday that U.S. regulators had delayed approving Avastin to treat breast tumors by more than a year.
The Food and Drug Administration requested further analysis of safety and effectiveness data on the new use of Avastin, currently approved for colon cancer, the South San Francisco company said.
Genentech said it might reapply by mid-2007, delaying approval until 2008.
Avastin’s U.S. sales, which rose 72% in the second quarter, are expected to slow.
Genentech, the world’s second-biggest biotechnology company, needs doctors to prescribe Avastin for breast cancer to meet analysts’ estimates, said Geoffrey Porges, an analyst at Sanford C. Bernstein &. Co. in New York. Porges had predicted that breast cancer would account for $1.4 billion, a quarter of Avastin sales, by 2010.
Genentech shares fell $3.74 to $78.83. It was the biggest one-day percentage decline since Jan. 11, 2005, when Avastin sales fell short of analysts’ estimates.
“The reason the shares are reacting this sharply is that this certainly raises the risk that Avastin in breast cancer may not come to market,” Porges said. “That would be a significant blow.”
Genentech filed for the expanded approval in May based on a study that showed combining Avastin with chemotherapy doubled the time women lived without a worsening of their breast cancer. At the time, the FDA had set a Nov. 23 deadline to rule on the use.
The study was sponsored by the National Cancer Institute under an agreement with Genentech and was conducted by the Eastern Cooperative Oncology Group, a network of cancer researchers.
Genentech met with the FDA before submitting the application and followed guidelines that the agency laid out for studies conducted by cooperative research groups, said Robert Mass, a principal medical director at Genentech.
The meeting took place to “agree upon the elements of the filing that would be acceptable,” Mass said. “We are a bit disappointed that the understanding has shifted.”
The FDA did not immediately comment.
