On the FDA’s Decision to Withdraw Avastin’s Breast Cancer Indication

November 18, 2011

They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

Significantly, the head of Roche/Genentech’s research arm vowed to pursue a new clinical trial that would look for biomarkers that might indicate which women might benefit from the drug. “We are disappointed with the outcome,” said chief medical officer Hal Barron. “We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States.”

Here’s how to interpret today’s decision. Anecdotes are not science. And those breast cancer patients who insist that Avastin is the reason why they are remaining alive longer than average will still have access to the drug. Why? If any insurance companies stop paying for Avastin’s use in breast cancer, the company is promising to make it available to anyone “who may be facing obstacles.” That won’t be many. Most insurance companies and Medicare will continue to follow the National Comprehensive Cancer Network guidelines. NCCN’s guideline writing committee, a third of whom have financial ties to Roche/Genentech, has said it will not withdraw Avastin’s use in metastatic patients. A few years ago, CMS passed a rule that said it would reimburse any use of a cancer drug, even if the FDA had not approved it for that use, if it was included in the NCCN guidelines and accompanying formulary.

That’s why we need guideline-writing committees without conflicts of interest.

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3 Responses to On the FDA’s Decision to Withdraw Avastin’s Breast Cancer Indication

  1. Greg Pawelski on November 18, 2011 at 10:32 am

    One breast cancer patient’s life saving therapy is another’s pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another.

    The solution to this problem is to investigate the VEGF targeting agents in each individual patient’s tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient’s outcome.

  2. Spring Texan on November 19, 2011 at 2:01 pm

    It’s just heartbreaking to me that we continue to pay high dollar for worthless treatments and meantime people who need it often can’t even afford tooth extractions (even people with Medicare) or perhaps cataract operations (if under 65).

    Heartbreaking and absolutely nuts.

    But yes, give enough people ANY treatment and some are gonna swear by it and be sure it saved them — colon cleaning or Avastin, they’ll be SURE of it, sigh.

  3. Greg Pawelski on November 23, 2011 at 10:13 am

    According to Tia Ghose at TheScientist, after the FDA revoked its approval of Avastin for the treatment of metastatic breast cancer, the drug maker says it will initiate new trials.

    In the wake of the US Food and Drug Administration’s decision to revoke approval of Avastin for the treatment of metastatic breast cancer, drug maker Genentech says it will conduct a new clinical trial to determine which patients are likely to benefit from the drug.

    The decision came after an advisory panel unanimously voted to revoke approval in June. The panel found that the drug only slightly decreased tumor size and didn’t increase lifespan compared to patients on standard chemotherapy.

    But many patients and doctors suspect the drug is helping at least some women. ”There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin,” Elisa Port, co-director of the Dubin Breast Center at Mt. Sinai Hospital in New York, told Reuters. But currently there is no way to identify those patients.

    After the announcement, Genentech said it would an initiate a new Phase III trial to determine if there are certain chemical or genetic markers that could help doctors determine which, if any, patients might get a survival boost from Avastin.

    The decision could cost Genentech and its parent company Roche up to $1 billion in sales a year, The New York Times reported. While doctors can still prescribe the drug off-label for use in metastatic breast cancer, the FDA decision could lead insurance companies to drop coverage for the drug, which costs nearly $100,000 a year, ABC News reported.

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