WASHINGTON/LONDON (Reuters) - Roche’s top drug Avastin should no longer be approved for breast cancer, U.S. health officials said on Thursday in an unusual move that could shave $1 billion from annual sales.
European authorities, meanwhile, recommended restricting the drug in breast cancer so it is given only with one type of chemotherapy.
Avastin, the world’s best-selling cancer medicine, has been approved for fighting breast and other cancers. But the drug failed to extend survival in four trials of patients with breast cancer.
“Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio,” Dr. Richard Pazdur, the U.S. Food and Drug Administration’s head of cancer drugs, told reporters.
Side effects include holes in the stomach and intestines, bleeding and blood clots.
Roche said that rates of these problems were low, at less than 4 percent in the breast cancer trials, and that Avastin provides meaningful benefit for patients with few choices for fighting an advanced cancer.
It said it would request a hearing to contest the U.S. decision.
If the FDA grants a hearing, there is no set date for when this would occur and until the procedure is concluded, Avastin will remain FDA-approved in breast cancer.
The drug, with a generic name of bevacizumab, will remain available for treating colon, lung, brain and kidney cancers.
But industry analysts estimate Roche could lose $1 billion of its $6 billion in annual sales from the expected slump in breast cancer use. Shares in the Swiss group ended 0.9 percent lower at 140 francs following the news.
“We expected a negative outcome in the United States. In Europe, we were more hopeful that the European Medicines Agency would maintain a broader label for Avastin in breast cancer,” Helvea analyst Karl-Heinz Koch said.
“We see sales halving to around 450 million Swiss francs ($464 million) in Europe. We now need to adjust our share price target to reflect the EU outcome.”
In Europe, the drug is still recommended as a treatment for advanced breast cancer with paclitaxel — the type of chemotherapy Roche said was most frequently used in the region — but not with docetaxel or capecitabine.
Recommendations from the EU drugs watchdog are normally endorsed by the European Commission in due course.
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.
Doctors could still prescribe the drug for breast cancer patients in the future, but U.S. insurance companies are unlikely to cover it without FDA approval. European healthcare systems may also be more reluctant to pay for it.
“Physicians should use medical judgment” to decide whether to keep prescribing Avastin for breast cancer, said Dr. Janet Woodcock, the FDA drugs chief.
Medicare, the U.S. health insurance for the elderly and disabled, will continue covering Avastin for breast cancer while Roche’s appeal continues, Woodcock said.
The FDA rarely removes approved uses from medicines for lack of benefit.
The Avastin case has drawn complaints from some U.S. lawmakers and split patient groups, with some arguing it helps some women and should remain an approved option.
Critics have accused the FDA, which is not allowed to consider cost, of limiting access to an expensive treatment. Avastin costs about $8,000 a month in the United States, although Roche caps the annual price at $57,000 per patient.
“The FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug,” Republican Senator David Vitter said in a written statement.
The FDA said it did not consider cost in the decision.
Britain already refuses to pay for Avastin for advanced breast cancer and the country’s healthcare cost agency last week gave the drug a poor assessment.
FDA officials said they were open to reviewing new research that could show the drug worked in certain women.
Avastin won U.S. clearance as a first-choice breast cancer treatment in 2008 under a process designed to bring new therapies to patients quickly. An initial study showed the drug stalled cancer growth by 5.5 months, but the FDA required Roche to confirm the drug worked. Later research found only a 1- to 3-month delay in breast cancer progression with no improvement in survival or symptoms.
Additional reporting by Katie Reid in Zurich and Bill Berkrot and Ransdell Pierson in New York; Editing by Xavier Briand