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An innovative breast cancer treatment has taken a step closer to the market as Swiss drugmaker Roche Holding AG submitted it for approval with American health regulators.
Roche revealed it filed trastuzumab-DM1 (T-DM1) – aimed at people with advanced HER2-positive breast cancer who had previously received other treatments – to the US Food and Drug Administration (FDA).
The company claims that its study has demonstrated that the drug shrank tumours in a third of women who had received an average of seven prior medicines for advanced HER2-positive breast cancer.
Roche also predicts that the new drug could eventually bring in sales of over £1.24 billion ($1.88 billion).
The news will also come as a boost for ImmunoGen, as the drug includes ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting antibody trastuzumab, or Herceptin. This would be the first product developed by ImmunoGen filed for approval.
When HER2-positive breast cancer is advanced, it means the disease has spread to other parts of the body, normally the brain, lungs, bones, and liver.
Copyright Press Association 2010