Roche will get the chance to support continued use in the USA of its blockbuster Avastin as a treatment for breast cancer at the end of June.
The US Food and Drug Administration announced in December that after a review of four clinical studies, it had concluded Avastin (bevacizumab) in combination with paclitaxel neither prolonged overall survival in metastatic breast cancer patients nor provided a sufficient benefit in slowing disease progression. As such, it began the process of removing the breast cancer indication from the drug’s label.
That decision followed a July review by an FDA advisory committee that voted 12-1 to remove the breast cancer indication. Avastin in combination with paclitaxel got the green light in February 2008 under the agency’s accelerated approval programme.
Roche vigorously disagreed with the FDA stance and its Genentech unit asked for a hearing last month. The agency has now informed the Swiss major that it has granted a hearing to allow the company the opportunity to present its views on why Avastin (bevacizumab) should remain FDA-approved for mBC on June 28-29.
Roche chief medical officer Hal Barron said "we appreciate the opportunity to continue our discussion with the FDA during a public hearing", adding that "we believe Avastin is an important option for women with this disease and should remain an FDA-approved choice".
How successful Roche will be is debatable given that the hearing will be in front of the FDA’s Oncologic Drugs Advisory Committee, which voted very firmly against Avastin in breast cancer in July. Genentech has argued that the panel does not have appropriate expertise, but presiding officer for the hearing Karen Midthun has written to the firm's lawyers saying that "we do not interpret FDA regulations as contemplating the substitution of a different advisory committee, and we do not intend to do so".
Dr Midthun added that "while I could add consultants to the advisory committee for this proceeding, we must face the reality that many experts in this area have already expressed a view on this issue and/òr might be considered as having conflicts because of their assoclation with one of the parties to the hearing or competitors to Genentech".