The world’s largest online community for physicians, Sermo, announced the publication of a free report about physicians? reaction to the FDA decision to rescind the indication for bevacizumab (Avastin?, Genentech) in the treatment of breast cancer. The report titled ‘Should Avastin (bevacizumab) Keep its Breast Cancer Indication?’ reveals how physicians are using bevacizumab and which therapeutic agents they will switch to for clinical presentations.
The report shows that 58% of physician respondents support the FDA’s move to pull the breast cancer indication from bevacizumab. However, 50% of respondents also believe that bevacizumab has increased the quality of life for breast cancer patients.
While bevacizumab is still approved for breast cancer patients, which means that women already taking the drug can continue to do so, Genentech, the drug?s manufacturer, no longer promotes bevacizumab as a treatment option for breast cancer.
The Sermo Debate
By leveraging Social Media Sermo engages physicians and facilitates discussions on a wide range of issues from clinical cases to advice about drugs and practice management. In the bevacizumab debate physicians provided commentary on both sides of the dispute. Some believe that the progression free survival benefit previously shown for bevacizumab is meaningful. According to one oncologist on Sermo, “…if folks can get ‘caught up’ on the survival endpoint by being able to take Avastin at the time of progression, how can one possibly prove a survival advantage overall.” Another oncologist commented, “This is a shame, but we are going to do what the payers let us do.”
Commenting on the controversy Jennifer Litton MD, Assistant Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston (TX), noted that she doesn?t routinely use bevacizumab outside clinical trials. While in some patients the use of bevacizumab has had a positive effect, she also said that others patients have developed blood clots and other side effects. “However”, she observed, “We don?t have any treatment for breast cancer that doesn?t have any negative effects.”
Alternatives
Therapeutic agents listed by the physicians participating in the debate that will be used instead of bevacizumab in the treatment of breast cancer include, but are not limited to paclitaxel (Abraxane?), docetaxel (Taxotere?), gemcitabine (Gemzar?), capecitabine (Xeloda?), paclitaxel (Taxol?), vinorelbine (Navelbine?) and ixabepilone (Ixempra?).
Many of the respondents also participated in an online discussion regarding the original bevacizumab study. The full report includes an overview of the FDA decision, key findings, discussion highlights changes in physician perception from 2009 to 2010 and therapeutic agents physicians will use in place of bevacizumab.
Opposite regulatory environment
While the FDA in the United States notified Genentech in December 2010 of its ?Proposal to Withdraw Marketing Approval? of bevacizumab for first-line treatment of metastatic HER2-negative breast cancer in combination with paclitaxel and issued a ?Notice of Opportunity for a Hearing? (NOOH) to allow the company an opportunity for a hearing on a proposal to withdraw the indication, the European Medicines Agency (EMA) confirmed that bevacizumab is a valuable treatment option in combination with paclitaxel.
The EMA also confirmed that bevacizumab has been convincingly shown progression-free survival, enabling women with metastatic breast cancer to live longer, and stated that ?the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.?
For more information:
– Process To Remove Breast Cancer Indication – Bevacizumab Not Shown To Be Safe and Effective In Breast Cancer Patients
– European Medicines Agency’s Review of Bevacizumab in Metastatic Breast Cancer Contradicts US FDA Assessment
– Bevacizumab Plus Chemotherapy in Early Breast Cancer is Feasible Treatment Option for Early HER2-Negative Breast Cancer.
