FDA advised to halt Avastin breast cancer use
pharmafile | July 21, 2010 | News story | Sales and Marketing | Roche, avastin
In a hammer blow to Roche, an influential Food and Drug Administration vote has gone against its cancer drug Avastin.
The FDA’s oncologic drugs advisory committee voted 12 to one that use of Avastin (bevacizumab) in previously untreated advanced HER2-negative breast cancer should be stopped.
“We are disappointed by the committee’s recommendation and believe Avastin should continue to be an option for women with this incurable disease,” said Sandra Horning, global head of clinical development haematology/oncology at Roche subsidiary Genentech, which manufactures Avastin.
However, Roche admits there is currently no proof that Avastin improves disease-related symptoms or survival for patients with the condition.
The recommendation from the committee does not affect Avastin’s current availability for US patients with breast cancer.
“We will continue to discuss the data from the more than 2,400 women who participated in three phase III studies with the FDA,” says Horning pointedly.
Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.
This decision was based on the phase III E2100 study and granted under the FDA’s accelerated approval programme.
In November 2009, the company submitted two supplemental Biologics License Applications to the FDA based on the AVADO and RIBBON 1 studies as part of the company’s effort to convert the accelerated approval to a full approval.
Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.
The FDA is expected to make a final decision on Avastin by the end of September, but whatever happens this committee’s recommendation does not impact the blockbuster cancer drug’s other indications.
It is currently approved in colon, lung, kidney and brain cancer.
In a much-needed boost for Roche, new data shows Avastin gives a median overall survival of 14.6 months with a range of chemotherapies in patients with advanced non-small cell lung cancer (NSCLC).
Survival with chemotherapy alone is typically less than one year. Results from the phase IV SAiL study of more than 2,000 patients, the vast majority of whom had adenocarcinoma, were published in The Lancet Oncology.
Two phase III clinical trials (E4599 and AVAiL) have already demonstrated that first-line Avastin-based therapy improves outcomes for patients with NSCLC.
Adam Hill
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