Roche's Herceptin cleared by UK for gastric cancer
The U.K.'s National Institute for Health and Clinical Excellence Wednesday said it recommended Roche Holding AG's (ROG.VX) Herceptin oncology drug be made routinely available on the publicly funded National Health Service to certain patients with metastatic gastric cancer.
- (1888PressRelease) November 29, 2010 - NICE said it approved use of Herceptin, also known as trastuzumab, for use "in combination with cisplatin and either capecitabine or 5-fluorouracil as an option for certain patients with metastatic adenocarcinoma of the stomach and gastro-oesophageal junction who have high levels of human epidermal growth factor receptor 2, or HER2."
HER2 is a protein found on the surface of some cancer cells. Trastuzumab attaches itself to the protein so that epidermal growth factor production is reduced in the cancer cells and this stops the cells from dividing and growing.
Carole Longson, NICE's Health Technology Evaluation Centre Director, said in a statement that "during consultation on the first draft guidance, Roche Products, the manufacturer of trastuzumab, submitted a new analysis on a subgroup of patients with the highest levels of HER2."
"The committee discussed this new information in the context of the supplementary advice to the committee on appraising a life-extending, end-of-life treatment and concluded that trastuzumab was cost-effective in this patient group."
Roche welcomed the decision, saying that study results have showed that the group of patients singled out by the regulator have an improved survival rate.
"Study results show that in the eligible group of patients median survival was increased from 12.6 months, for patients receiving just chemotherapy, to 18 months, for patients receiving trastuzumab plus chemotherapy," Roche said.
Gastric cancer, also known as stomach cancer, including cancer of the gastro-oesophageal junction affects approximately 7,700 people in the UK every year of whom around 350 would be suitable for treatment with trastuzumab, NICE said, adding that it has the potential to extend the lives of those patients with high levels of HER2 by more than three months. The average life expectancy for people with metastatic gastric cancer is around one year.
For Roche, the UK regulator's comes as a relief after the Swiss pharmaceuticals giant has repeatedly failed to win approval for its cancer drug Avastin to treat bowel cancer.
The regulator has repeatedly rejected to reimburse the medicine, saying the drug's effectiveness is too small when compared to the drug's high price. A similar concern threatens to hurt the drug's sales in the U.S., where regulators are currently discussing its use in treating breast cancer.
Avastin and Herceptin as well as Mabthera are Roche's top selling medicines, each netting more than 5 billion francs per year.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall ( @ ) dowjones dot com
Copyright ©2010 Dow Jones & Company, Inc. All Rights Reserved
Source: The Wall Street Journal
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