WASHINGTON — Decision the FDA, the requesting the withdrawal of the indication of bevacizumab (Avastin) breast cancer was no great surprise to many experts of breast cancer.
However, oncologists expressed mixed views about the decision. Some agreed with the FDA that four clinical trials of the drug has not demonstrated a substantive effect on metastatic breast cancer. Others worry about the potential loss of approved therapy that has helped some patients.
Others simply expressed disappointment and frustration with research into more effective treatments for metastatic breast cancer.
"We all have seen patients who have clearly benefited the addition of AVASTIN to chemotherapy in this context," Gary Lyman, MD, Duke University in Durham, N.C., said MedPage Today in an email. "The major problem is that we do not have a biomarker or an indicator which will benefit and who will only further experience, sometimes serious, toxicity, as we have for agents hormones, trastuzumab (Herceptin) and others.
"Bevacizumab is clearly active in other cancers, and will continue to be available but will be limited role in breast cancer until we have a marker to indicate who will be without doubt benefit," he said.
Lyman sitting on the FDA oncology drugs Advisory Committee (ODAC) who voted against the approval full of bevacizumab for use in combination with chemotherapy for metastatic breast cancer.
The voting seems to fly to positive results in clinical trial E2100, conducted by the Eastern Cooperative Oncology Group. That trial has caused a wave of enthusiasm in the breast cancer community by showing an increase of double (SFP) progression-free survival in patients treated with paclitaxel more bevacizumab versus paclitaxel alone.
"The vote does not grant full approval of bevacizumab for first-line metastatic breast cancer is one of the most heartbreaking those that I can remember," Lyman said. "We were all enthusiastic E2100 previous results in combination with paclitaxel and recommended for accelerated approval pending additional test data.
Unfortunately, none of the trials showed an impact on survival of patients and the impact on the progression of the disease was much more modest - or non-existent - compared to the original test. In addition, it y little or no data suggesting an impact on the quality of life of the patient or other outcomes in patients concerned. »
Francisco Esteva, MD, the MD Anderson Cancer Center in Houston, Texas. also deplored the failure of the other three clinical trials to confirm or build on the results of E2100, as well as the absence of biomarkers to identify patients most likely to benefit from bevacizumab.
"There was a small improvement in progression-free survival and no improvement in overall survival, I'm surprised the FDA step took this action, but of course, I'm disappointed," Esteva said in an interview with MedPage today. "We must therapies more, not less."
Breast surgeon Susan Love, MD, Santa Monica, California, said noted shortcomings in the current approach to drug development FDA decision points.
"I think that the FDA is right." We have spent far too much energy on drugs which only add a month or two to the lives of women and consider even felt during this time the woman "love said today MedPage e-mail." "More is not always better." We must be finding medicines which are shots of circuit, not very slightly better, and we must find the cause of the disease and stop it.
Dallas oncologist David Euhus, MD, echoed the sentiments of love in an email.
As with any targeted therapy, Avastin is efficient in the subgroup of patients with breast cancer are dependent on track, the blocks of the agent,"said Euhus, of the University of Texas Southwestern Medical Center. "A"one-size-fits-all"approach is not viable in the modern era of personalized medicine."
"I am very concerned that pharmaceutical companies have an economic interest in the advancement of agents for which they can get very broad indications of only." This will create a bottleneck in the testing and licensing of targeted therapies, "Euhus said MedPage today."
Some observers have different concerns the decision by the FDA. Edith Perez, M.D., Jacksonville, Florida, Mayo Clinic said the FDA changed the rules of assessment bevacizumab.
"I am very troubled by this situation, Perez said in an interview with MedPage Today at the San Antonio Breast cancer Symposium before the announcement of the FDA." Clinical trials have been designed for progression-free survival, and they have shown an advantage. The FDA now seems to be rethinking the situation, saying that the drug did not improve overall survival.
Issues are more complex, 60% of patients originally assigned to the chemotherapy alone went to bevacizumab for tracking, it is difficult to look at the overall survival. "I think it is unfair that bevacizumab should be removed on overall survival, because we clear the drug improves progression-free survival and improves survival statistically a year," said Perez.
Esteva also disputed review FDA bevacizumab breast cancer indication, saying that it seems that more weight is given adverse drug for its effectiveness.
Susan g. Komen for the cure, the largest organization devoted exclusively to cancer of the breast, planet is concerned about the potential effect of decision from the FDA on women who received treatment with bevacizumab.
"We want to ensure that women who are using AVASTIN, for which he works, can continue to access their insurers will continue to pay and that Roche/Genentech drug manufacturer continues to make the drug available to women by supporting patient programs and considers an expanded access program,"President Komen Elizabeth Thompson said in a statement.""
Thompson also implored breast cancer researchers to pursue the quest for biomarkers that to identify patients most likely to benefit from treatment with bevacizumab subgroups.
Genentech announced intentions to appeal the decision to request a review and public hearing. Society representatives scheduled a teleconference with media at 3 p.m. et today to discuss the decision by the FDA.
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