Tags: Top Roche Drug Could Lose Breast Cancer Approval

Top Roche Drug Could Lose Breast Cancer Approval

Thursday, 16 Dec 2010 10:20 AM

U.S. and European officials may decide this week that Roche's top drug should no longer be approved for breast cancer, an unusual step that could shave $1 billion from annual sales as insurers refuse coverage.

Avastin is the world's best-selling cancer medicine and one of the most expensive, a fact that fuels controversy. It carries approval for fighting breast and other cancers, but the drug has not extended survival or improved symptoms in any study of patients with breast cancer.

The U.S. Food and Drug Administration is expected as early as Friday to seek the removal of breast cancer as an approved use. The drug would remain available for treating bowel, lung, brain and kidney cancers. The European Medicines Agency also may rule at a monthly meeting of experts that ends Thursday.

The case has drawn complaints from some lawmakers and split patient advocates.

"If meaningful benefit cannot be established for a cancer therapy, particularly one with serious side effects, drug approval must be revoked in order for trust in the regulatory system to be maintained," said Fran Visco, president of the National Breast Cancer Coalition.

Others say Avastin helps some women and should remain an approved option. One petition delivered to the FDA in support of the drug carried about 9,500 signatures.

Some lawmakers have accused the agency, which is not allowed to consider cost, of trying to limit access to an expensive treatment. The medicine costs about $8,000 a month. Roche caps the annual price tag at $57,000 per patient.

Five Republican lawmakers wrote to FDA Commissioner Margaret Hamburg last month voicing concern the Obama administration was "overreaching into the personal healthcare options of Americans."

"We are struggling to see any justification other than cost," Representative Kay Granger and four other lawmakers wrote.

Britain already refuses to pay for Avastin for advanced breast cancer. The country's healthcare cost agency last week gave the drug a poor assessment.

Industry analysts estimate Roche could lose $1 billion of its $6 billion in annual sales if Avastin loses its U.S. and European licenses for breast cancer. Doctors could still prescribe the drug for breast cancer patients, but insurers would be unlikely to cover it without FDA approval.

Roche could request a hearing and appeal any decision to remove the breast cancer use.

Avastin won U.S. clearance for breast cancer in 2008 after a study showed the drug stalled cancer growth by 5.5 months. The FDA required Roche to confirm the drug worked. Later research found only a one- to three-month delay in breast cancer growth with no improvement in survival or symptoms.

After reviewing Roche's latest research, an FDA panel of outside experts voted 12-1 in July to urge withdrawal of the drug's approval for breast cancer. Members said they were not convinced Avastin provided any worthwhile benefit in that setting to justify serious risks including blood clots.

Avastin's risks include gastrointestinal perforations, bleeding and blood clots. Roche said rates of those problems were low, at less than 4 percent in the breast cancer trials.

The company argues Avastin provides meaningful benefit for patients with few choices for fighting an advanced cancer.

"We continue to believe Avastin should be an option" for women with advanced breast cancer, said Charlotte Arnold, a spokeswoman for Roche unit Genentech.

Patient advocates are encouraging Genentech and insurers to help women currently on Avastin to stay on it if the approval is revoked.

Many women take the drug now and have "a high quality of life," said Elizabeth Thompson, president of Susan G. Komen for the Cure.

Roche has a separate application pending with the FDA seeking approval of Avastin as a second-choice treatment for advanced breast cancer after initial therapy fails. The deadline for that decision is May 19.

Avastin was once expected to become the world's biggest selling drug by 2014, but its prospects have faded after doubts over its benefits in breast cancer and after it failed in clinical trials for prostate and stomach cancer. The drug's generic name is bevacizumab.

© 2017 Thomson/Reuters. All rights reserved.

   
1Like our page
2Share
Companies
U.S. and European officials may decide this week that Roche's top drug should no longer be approved for breast cancer, an unusual step that could shave $1 billion from annual sales as insurers refuse coverage. Avastin is the world's best-selling cancer medicine and one of...
Top Roche Drug Could Lose Breast Cancer Approval
668
2010-20-16
Thursday, 16 Dec 2010 10:20 AM
Newsmax Inc.
 

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
MONEYNEWS.COM
© Newsmax Media, Inc.
All Rights Reserved