RxNews® - Clinical Updates
Avastin® (bevacizumab) – FDA Commissioner Revokes Breast Cancer Indication
- On November 18, 2011, the FDA Commissioner revoked the approval of Avastin’s (bevacizumab) indication for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer in combination with paclitaxel. Avastin, manufactured by Genentech, has not been shown to delay tumor growth, increase overall survival or increase quality of life for this indication.
- The Commissioner's decision to revoke the breast cancer indication will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers. Avastin will remain on the market; however, the breast cancer indication must now be removed from the prescribing information.
- Avastin is currently approved for the following indications:
- First- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy.
- First-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel.
- Treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.
- Treatment of metastatic renal cell carcinoma in combination with interferon alfa.
- The Commissioner's decision is based on a review of the arguments and evidence presented at a hearing held in June 2011, briefs filed by both the Center for Drug Evaluation and Research and Genentech before and after the hearing, public comments, and data from clinical trials.
- A meta-analysis of three randomized trials (E2100, AVADO, RIBBON-1) evaluated bevacizumab + first-line chemotherapy regimens (taxane-, anthracycline-, or capecitabine-based) in patients with metastatic breast cancer (n = 2,447). Duration of follow-up ranged from 29-36 months.
- In the pooled analysis, median progression free survival improved from 6.7 to 9.2 months [hazard ratio (HR) = 0.64, p < 0.0001) in the bevacizumab arms.
- Pooled results for overall survival showed no statistically significant difference between the treatment arms [control: 26.4 months; bevacizumab + chemotherapy: 26.7 months (HR = 0.97, p = 0.56)].
- One year survival rate was greater in the bevacizumab + chemotherapy arms (control, 76.5%; bevacizumab + chemotherapy, 81.6%, p = 0.003).
- In October 2010, the National Comprehensive Cancer Network (NCCN) updated the NCCN Clinical Practice Guidelines for Oncology for Breast Cancer to affirm the recommendation regarding the use of Avastin as a therapeutic option in the treatment of metastatic breast cancer. The NCCN placed a 2A designation (ie, based on lower level evidence and uniform NCCN panel consensus) for this recommendation.
- Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first or second line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.
- According to the Centers for Medicare and Medicaid (CMS), Medicare will continue to cover Avastin. CMS will monitor and evaluate coverage options as a result of the FDA decision, but there are no immediate plans to change coverage policies.
- Genentech provided additional information for healthcare professionals and patients:
- Genentech will issue a letter to healthcare professionals and will also provide them with a letter to distribute to their patients. Both letters will be made available on Genentech's website soon.
- Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.
- Doctors with questions about Avastin can call Genentech's Medical Communications group at (800) 821-8590.
- The FDA's decision does not impact ongoing trials with Avastin in breast cancer. Information on clinical trials of Avastin can be obtained from Genentech's Trial Information Support Line at (888) 662-6728 or www.clinicaltrials.gov.
- Despite the decision, Genentech will start a new phase 3 study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which patients might derive a more substantial benefit from Avastin.
- Below lists past Clinical News Summaries which address Avastin and its use in metastatic breast cancer:
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