Roche Holding (RHHBY) recently announced survival data from its phase III CLEOPATRA study on Perjeta (pertuzumab).
Data from the study showed that Perjeta plus Roche’s existing breast cancer drug Herceptin (trastuzumab) and docetaxel chemotherapy significantly improved overall survival in patients suffering from previously untreated HER2-positive metastatic breast cancer (mBC) in comparison to the combination of Herceptin, chemotherapy and placebo.
The risk of death was reduced by 34% in patients who received the combination of Perjeta, Herceptin and chemotherapy in comparison to patients receiving the combination of Herceptin and chemotherapy. On the basis of favorable data, Perjeta was offered to patients receiving the Herceptin and chemotherapy combination in the CLEOPATRA study. The updated data did not provide any new safety signals.
We note that in June this year, the US Food and Drug Administration (:FDA) approved Perjeta plus Herceptin and docetaxel chemotherapy for treating HER2-positive mBC in patients who did not receive prior anti-HER2 therapy or chemotherapy for metastatic disease. The FDA’s decision was based on positive results from the CLEOPATRA study.
Roche also received approval for Perjeta in Switzerland and Mexico in August and September, respectively, this year. Roche is also looking for the EU approval of the drug having already submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (:EMA).
HER2-positive cancer, an aggressive form of breast cancer, affects 15–20% of the total breast cancer population. Herceptin sales were up 12% year over year during the first nine months of 2012. Apart from Herceptin, other treatments in the market for HER2-positive breast cancer include GlaxoSmithKline's (GSK) Tykerb.
The strengthening of the breast cancer portfolio at Roche should boost the top line further since the market for breast cancer, the most common form of cancer affecting women globally, offers significant commercial potential.
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