Roche and the Breast International Group (BIG) on 1 October announced final results from the Phase III HERA trial, which confirmed that one year of Herceptin (trastuzumab) treatment remains the standard of care for people with early-stage HER2-positive breast cancer. These data showed that there was no difference in the time women lived without their disease returning (disease-free survival) when they received Herceptin for two years versus one year, a secondary endpoint of the study. After a median follow-up of eight years, the improvements in disease-free survival and overall survival for women who received Herceptin for one year remained statistically significant compared to women who underwent observation alone. There were no new safety findings in the study.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of the first medicine specifically for the symptomatic treatment of irritable bowel syndrome (IBS) in the European Union (EU).
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, is a fatal, rapidly progressive neurodegenerative disorder characterised by weakness, muscle atrophy and spasticity due to the selective loss of both upper and lower motor neurons. ALS is the most common motor neuron disease, affecting more than 86 000 people worldwide, and with an average life expectancy of three to five years from onset. There is currently no cure for ALS, while most treatments, such as Sanofi-Aventis’s Rilutek (Riluzole), only succeed in prolonging life by a moderate extent. Hence, given the great unmet need, novel treatments with improved efficacy are needed.
On 31 August, nine Japanese pharmaceutical companies (Kyowa Hakko Kirin, Takeda Pharmaceutical, AstraZeneca, Mitsubishi Tanabe Pharma, Eisai, Astellas Pharma, Abbott Japan, Shionogi & Co and Taisho Pharmaceutical) announced that they had jointly submitted an application to Japan’s Ministry of Health, Labour and Welfare for the approval of a therapy aimed at the elimination of Helicobacter pylori (H. pylori) infection.