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news.To the delight of the drug's many supporters, Roche has submitted a marketing authorization application to the European Medicines Agency for Herceptin as adjuvant treatment for early-stage HER2-positive breast cancer.
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The European filing for Herceptin follows a similar filing in the US submitted by Genentech, the drug’s inventor. The license applications seek to expand the approved indications for the drug, which is already available for the advanced form of the disease.
The drug is set to receive a fast tracked review which could see it approved in the extended indication before the end of the year.
The application is based on data from the international HERA study, which showed that Herceptin following standard chemotherapy reduces the risk of cancer coming back by 46%.
HER2-positive breast cancer, which affects approximately 20-30% of women with breast cancer, demands special and immediate attention because HER2-positive tumors are fast-growing.
Results from four large trials, with nearly 12,000 patients analysed from around the globe, provide consistent evidence that Herceptin reduces the risk of cancer coming back by about 50%, providing the best chance of long-term survival to women with this aggressive form of early-stage breast cancer.
“The outstanding benefits we have seen from Herceptin as post-surgical therapy for early-stage breast cancer underpin the importance of securing patient access to this drug as quickly as possible,” commented Ed Holdener, head of Roche’s Global Pharma Development.