Parent company Roche and its American subsidiary, Genentech, dodged a bullet Wednesday from the European medical community for its first-of-its-kind drug Avastin. But the pharmaceutical companies received less positive news in the United States. The cancer treatment drug should not be used against breast cancer in the United States, according to a unanimous vote by the six-member oncology drug review panel of the U.S. Food and Drug Administration, as reported by The Globe and Mail.
Just as the non-binding vote by the FDA's drug review panel was taken, the European medical community broadened the labeled use of Avastin as a first-line treatment of metastatic breast cancer in combination with another chemotherapy agent, Xeloda, reports GEN News.
Avastin, trade name for bevacizumab, was originally approved by the FDA in February 2004 as a first-line treatment for metastatic colorectal cancer. The creation of the genetically engineered mouse antibody was the culmination of 30 years of research, making Avastin the first approved drug that slows the growth of blood vessels in tumor cells, according to the National Cancer Institute.
Since that time, Avastin has also received FDA approval for the treatment of non-small cell lung cancer; glioblastoma; renal cell cancer; and, in 2008, metastatic breast cancer in combination with paclitaxel. Drug warnings regarding side effects related to the use of bevacizumab were issued in 2004, 2006 and again in 2007, listing such occurrences as strokes, heart attacks, nasal septum perforation and development of fistulas in the throat, bladder, vagina and liver, among other organs.
At issue for the use of Avastin in the treatment of breast cancer in the United States is that clinical studies have failed to demonstrate any appreciable extension of life for women who have undergone therapy. The term used by the FDA for extension of life is "progression-free survival" and is a prime factor in determining label use for an oncology medication.
The decision Wednesday by the FDA advisory committee followed a two-day hearing requested by Roche/Genentech to appeal the FDA's December 2010 consideration of removing the use of Avastin against breast cancer from the medication's label list of uses.
Physicians may still use Avastin in the treatment of breast cancer even if the FDA agrees with the advisory committee's recommendation. The chemotherapy treatment comes with an average cost of $88,000 per year, reports The New York Times. Many insurance companies will not cover off-label use of medications, although Medicare and Medicaid will continue to pay for the drug's use, even if done off-label.
Roche plans further research studies in the future for the medication's breast cancer use; time will tell what new data will reveal. In the meantime, women who have no other hope for treatment of their breast cancer may be trying to find the funds to pay for the chemotherapy medication that offers the only glimmer of hope.
Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of "The Red Man" state. With what he hopes is an everyman's view of life's concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.
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