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Genentech Plans New Avastin Trial

After the FDA revoked its approval of Avastin for the treatment of metastatic breast cancer, the drug maker says it will initiate new trials.

By | November 21, 2011

PET/CT Scan of breast cancerWIKIMEDIA COMMONS, HG6996

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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Comments

Avatar of: kenwil

kenwil

Posts: 5

November 22, 2011

Wow - no real effect and increadibly expensive. I wonder how much Genentech made out of it and how big the execs bonuses were. Perhaps there should be be a "money back" rule for expensive drugs that are found to not work. That would concenrate the minds of the drug company execs!

Avatar of:

Posts: 0

November 22, 2011

Wow - no real effect and increadibly expensive. I wonder how much Genentech made out of it and how big the execs bonuses were. Perhaps there should be be a "money back" rule for expensive drugs that are found to not work. That would concenrate the minds of the drug company execs!

Avatar of:

Posts: 0

November 22, 2011

Wow - no real effect and increadibly expensive. I wonder how much Genentech made out of it and how big the execs bonuses were. Perhaps there should be be a "money back" rule for expensive drugs that are found to not work. That would concenrate the minds of the drug company execs!

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