Roche Holding announced it will submit its breast cancer drug Pertuzumab towards the end of 2011 for approval in the USA and Europe after Genentech (a Roche company) said its Phase III clinical evaluation of the Pertuzumab and trastuzumab (Cleopatra) trial met its main goal (primary endpoint).
The trial showed that administering Pertuzumab and Herceptin (trastuzumab), along with docetaxel chemotherapy to patients with HER2-positive metastatic breast cancer (mBC) helped them live longer (without disease getting worse) than those only on Herceptin and docetaxel.
No additional side effects to the ones already registered in previous studies were detected. The registered side effects included weight loss, diarrhea, fever and fatigue.
Hal Barron, M.D., Roche’s chief medical officer and head, Global Product Development, said:
“These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalised options for people with this aggressive disease. We plan to submit the study results for global regulatory approval this year.”
Approximately 20% of all breast cancer patients are affected by HER2-positive breast cancer. Roche researchers inform that despite considerable progress, this type of breast cancer is still an incurable disease.
The company says it will provide data in more detail regarding this trial during its next medical conference later on in 2011.
Like Hertceptin, Pertuzumab neutralizes the HER2 protein, which is linked to tumor growth. Both drugs were developed by Genentech Inc., which Roche took over in 2009 for $46.8 billion.
When/if the drug becomes approved, experts predict it will reach sales in the billions of dollars.
Regulatory authorities have put Roche under pressure regarding its current breast cancer drug Avastin. The US FDA (Food and Drug Administration) has been questioning the drug’s benefits, even though Roche stresses it helps patients live longer without disease progression. Earlier this year the company reduced its peak sales forecast for Avastin to 7 billion francs ($8.57 billion), a 20% cut.
1.4 million new breast cancer diagnoses are made annually worldwide, it is the most common cancer among females. 450,000 women die each year from the disease.
In HER2-positive breast cancer, higher amounts of HER2 (epidermal growth factor receptor 2) are present on the surface of tumor cells – known as “HER2 positivity”. It is the most aggressive form of breast cancer and affects between 15% and 25% of women with breast cancer.
99% of all breast cancers are diagnosed in women, 1% in men.
Written by Christian Nordqvist