Today in breast cancer news, we'll wrap up the week's big story by looking at what's next for Avastin. We'll also look at a UK decision to deny cost coverage for Tykerb or Herceptin plus hormone therapy for some metastatic patients and surgical scar treatment and prevention advice.
What's next for Avastin?
There's been a great deal of activity on the LATESTBreastCancer.com Avastin (bevacizumab) news page this week. Earlier this week, an FDA advisory panel held hearings on the risks and benefits of Avastin for metastatic breast cancer. In the end, the panel voted 6-0 against the use of Avastin for breast cancer. The FDA Commissioner will make the final decision, which will likely follow the panel's recommendation.
So, what's next for Avastin?
First, because Avastin will still be available for other cancers, doctors may continue to prescribe it off-label for metastatic breast cancer. At a cost of about $8,000 a month, the real question is if insurance will continue to pay.
According to the New York Times, Medicare will continue to cover Avastin for metastatic breast cancer even if the FDA revokes approval. This may eventually change, but such a change in policy "would take at least a year and involve public input." Representatives from several private insurance companies indicated that they would review coverage after the FDA final decision. A UnitedHealthcare representative told the New York Times that it would continue to base chemotherapy coverage on National Comprehensive Cancer Network (NCCN) guidelines.
A Reuters story noted that Roche is "undeterred" and is planning another breast cancer trial for early 2012. The new trial will include a biomarker to try to identify which patients may benefit from Avastin.
Both the New York Times and Reuters mentioned that Europe expanded its approval for Avastin for breast cancer to allow it to be combined with a second type of chemotherapy, Xeloda (capecitabine). Avastin "can be used for breast cancer in more than 80 countries."
UK won't pay for Tykerb or Herceptin plus hormone therapy for some patients
In foreign regulatory news, Bloomberg reports that the UK National Institute for Health and Clinical Excellence has denied cost coverage for Tykerb (lapatinib) or Herceptin (trastuzumab) in combination with aromatase inhibitor therapy for older, HER2 positive, metastatic patients. Unlike the recent Avastin hearing, the UK decision was based on a cost/benefit analysis. Both Tykerb and Herceptin have previously been approved in the UK for use in "certain other patients."
Breast cancer surgical scar prevention and treatment
According to a recent Cure Today article, surgical scars "can be managed and minimized." Breast surgeries, such as breast conserving surgery (lumpectomy) and mastectomy, are "associated with a high incidence of scarring." The International Advisory Panel on Scar Management recommends silicone gel sheeting be used as the "first-line preventative measure" for the first month after surgery. For more severe cases, intralesional corticosteroid injections are recommended as second-line treatment. Pressure wrapping may also be an option. In some cases, surgical excision may be necessary.
Please check back on Monday for more breast cancer news updates from LATESTBreastCancer.com. You may find all the news and research on any breast cancer test or treatment option, including complementary therapies on our website anytime.
Thursday, June 30, 2011
The Breast Cancer News Update: June 30
With all the coverage of the Avastin hearing, yesterday was the most one-sided breast cancer news day we can remember.
But if you're following this story you might find it worthwhile to quickly see how different respected news organizations like The New York Times, Washington Post, LA Times, US News and World Report and others all covered it by accessing all their links from our single Avastin news page.
I should mention one interesting take on the Avastin: a blog entry by Dr. Debu Tripathy on the CureToday site (link). Dr. Tripathy calls the Avastin hearings "the end of an era in drug discovery." He does a nice job summarizing the situation and then links it to drug companies' need to do more research to identify predictive tests for new drugs.
If such a test existed for Avastin (in the same way that HER2 testing identifies patients who should receive Herceptin) then those Avastin patients who testified at the hearing wouldn't have to pit their own personal clinical benefit against the large number of patients who get no benefit, only side effects.
As Dr. Tripathy stated: "It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes. The FDA hearings mark a milestone in this turn - the end the old era of cancer drug development."
...and another step toward the inevitable: truly personalized medicine.
Anyway, regarding other stories yesterday, we won't waste your time. All were either repeats of stories we've already mentioned or weren't of broad relevance.
More tomorrow.
But if you're following this story you might find it worthwhile to quickly see how different respected news organizations like The New York Times, Washington Post, LA Times, US News and World Report and others all covered it by accessing all their links from our single Avastin news page.
I should mention one interesting take on the Avastin: a blog entry by Dr. Debu Tripathy on the CureToday site (link). Dr. Tripathy calls the Avastin hearings "the end of an era in drug discovery." He does a nice job summarizing the situation and then links it to drug companies' need to do more research to identify predictive tests for new drugs.
If such a test existed for Avastin (in the same way that HER2 testing identifies patients who should receive Herceptin) then those Avastin patients who testified at the hearing wouldn't have to pit their own personal clinical benefit against the large number of patients who get no benefit, only side effects.
As Dr. Tripathy stated: "It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes. The FDA hearings mark a milestone in this turn - the end the old era of cancer drug development."
...and another step toward the inevitable: truly personalized medicine.
Anyway, regarding other stories yesterday, we won't waste your time. All were either repeats of stories we've already mentioned or weren't of broad relevance.
More tomorrow.
Tuesday, June 28, 2011
The Breast Cancer News Update: June 29
There were two dominant breast cancer stories yesterday: day 1 of the 2-day Avastin FDA hearing requested by Genentech, and new results from a Swedish study that reaffirm the value of screening mammography.
Avastin appeal hearing, Day 1
Can Genentech and activist patients convince the F.D.A. to reverse its December 2010 decision to revoke the drug’s approval for treatment of advanced breast cancer? All day yesterday I was getting minute-by-minute tweets live from the hearing. Most of the news coverage yesterday was about the passion of patients and doctors who believe they are benefiting from the anti-angiogenic drug. Genentech is on their side. But the FDA believes, based on several studies published since the provisional approval, that the drug's side effects and risk are real while the benefits are not. Day 2 is today. The story continues. Check out our Avastin page for all of yesterday's coverage by the respected news sources that we track.
Mammography: New data from a 30 year Swedish study
Breast screening recommendations issued in 2009 by the U.S. Preventive Services Task Force caused an uproar among medical professionals and women in their 40s. Yesterday, new results from a large, ongoing Swedish study suggested that the benefits of screening mammography increases the longer you follow women. This includes women in their 40s. So while screening mammography has risks and benefits, particularly in this age range... and while decisions about screening should be made by women and their physicians, these results point to a larger long-term benefit in terms of reduced deaths than was earlier appreciated. There are several articles listed at the top of our screening mammography page.
As always, more tomorrow.
Avastin appeal hearing, Day 1
Can Genentech and activist patients convince the F.D.A. to reverse its December 2010 decision to revoke the drug’s approval for treatment of advanced breast cancer? All day yesterday I was getting minute-by-minute tweets live from the hearing. Most of the news coverage yesterday was about the passion of patients and doctors who believe they are benefiting from the anti-angiogenic drug. Genentech is on their side. But the FDA believes, based on several studies published since the provisional approval, that the drug's side effects and risk are real while the benefits are not. Day 2 is today. The story continues. Check out our Avastin page for all of yesterday's coverage by the respected news sources that we track.
Mammography: New data from a 30 year Swedish study
Breast screening recommendations issued in 2009 by the U.S. Preventive Services Task Force caused an uproar among medical professionals and women in their 40s. Yesterday, new results from a large, ongoing Swedish study suggested that the benefits of screening mammography increases the longer you follow women. This includes women in their 40s. So while screening mammography has risks and benefits, particularly in this age range... and while decisions about screening should be made by women and their physicians, these results point to a larger long-term benefit in terms of reduced deaths than was earlier appreciated. There are several articles listed at the top of our screening mammography page.
As always, more tomorrow.
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