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U.S. panel to review two proposed Avastin uses
WASHINGTON |
WASHINGTON (Reuters) - A U.S. advisory panel will meet in July to review two proposed new uses for Roche Holding AG's blockbuster cancer drug Avastin, the Food and Drug Administration said on Thursday.
The committee of outside experts at a July 20 meeting will consider applications from Roche unit Genentech to promote Avastin for certain patients with advanced breast cancer, the FDA said.
The company is seeking approval of Avastin as a first-choice treatment for patients with metastatic HER2-negative breast cancer in combination with the chemotherapy drug docetaxel, or with other chemotherapy drugs.
Avastin, Roche's biggest product, already is approved for treating various types of colon, breast, lung and other cancers.
The FDA panel also will consider studies Genentech has submitted to win full approval of Avastin for use with the drug paclitaxel in some breast cancer patients who have not received chemotherapy.
That use was cleared based on an abbreviated process that requires follow-up studies to confirm the drug's benefits.
Some investors have been nervous that Genentech's confirmatory findings were not strong enough and the FDA might withdraw approval for that use.
Deutsche bank analysts, however, said earlier this month that recent data could soothe those concerns. Results to be presented at an upcoming cancer meeting showed Avastin extended the time patients lived without their cancer growing when used as a first-choice treatment for advanced breast cancer.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
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