UPDATE 2-Genentech gets U.S. hearing on Avastin, breast cancer

Genentech has won a second chance to convince U.S. regulators that its Avastin drug is a safe and effective treatment for breast cancer.
The drugmaker, part of Roche Holding AG (ROG.VX), has been fighting a Food and Drug Administration ruling last year that called on the company to stop marketing the cancer drug for use in women with breast cancer.
In a letter sent to Genentech's lawyers on Wednesday, the FDA agreed to give the company a public hearing on the issue at a two-day meeting with outside agency advisers June 28 and 29.
"We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer," Genentech's chief medical officer Hal Barron said in a statement announcing the letter on Thursday. He added that the drug is an important option for women and should remain FDA-approved.
The move is a win for the biotech company, which has been fighting the FDA's Dec. 16 decision to remove the breast cancer indication for Avastin. At the same time, European officials halted such use except when given with one type of chemotherapy.
Genentech refused to remove the breast cancer use from the drug and instead vowed to fight the agency's decision, asking for a public hearing.
Stripping the breast cancer indication would not prevent doctors from using it in such women, but it would likely give health insurance companies a reason to deny payment. Also, Genentech would not be able to promote Avastin for that use.
The issue sparked a flurry of objections from some politicians and patient groups who accused the agency of trying to limit patient options and dictate medical care.
The June hearing is likely to be just as controversial.
Genentech has told the FDA it does not want the agency's cancer advisers to weigh the case because they lack appropriate expertise, according the letter. But FDA lawyers told the company that is the only appropriate committee to consider the issue.
It also called on the company to work with the FDA to outline facts in the case so the meeting can focus on issues in dispute, FDA said.
It did not say when or where the meeting would be held but told the company details would come later.