WILL ROCHE LOSE AVASTIN INDICATION FOR BREAST CANCER?-STAY TUNED FOR 20 JULY FDA MEETING

Last week was a big one for high-profile FDA advisory panel meetings, with GlaxoSmithKline’s diabetes drug Avandia and Vivus’s experimental weight-loss drug Qnexa up for discussion. (See here for how the panel’s vote on Avandia went down and here for the Qnexa vote.)

And now it’s cancer drug Avastin’s turn in the FDA-committee spotlight, as the WSJ reports. On Friday the agency posted briefing documents to its website in advance of tomorrow’s oncology-drugs advisory panel meeting — and that material suggests it may be a rough day in Rockville for Roche.

The difference in benefit between women being treated with Avastin plus chemo and chemo alone “is not clinically meaningful,” and side effects were more concerning in members of the Avastin group, the paper says. The risk-benefit ratio of adding Avastin “may not be considered favorable,” the FDA documents said.

Avastin already received accelerated approval as a treatment, in combination with one type of chemo, for the most common type of advanced breast cancer. Now Roche is back with two other studies, hoping to gain full approval for the drug as well as for its use with other chemo drugs.

In a research note, Bernstein analyst Tim Anderson says the panel’s options include advising withdrawal of approval for the drug’s use against breast cancer, keeping things as they are without expanding its use and expanding its use.

He writes that the FDA’s briefing materials have increased caution, saying the meeting may be “a close call.” He estimates that front-line breast cancer treatment in the U.S. accounts for about $500 million of Avastin’s $6.5 billion in sales, and that an FDA withdrawal of marketing approval would curb but not likely totally eliminate these sales. Such a move would likely hit earnings per share “on the order of low to mid single digits percent,” but he says “the impact to share price would likely be bigger than this” due to high investor expectations.

Roche says the drug is safe and effective.