) recently announced that the European Medicines Agency (EMA) has
approved Perjeta (pertuzumab) as a combination therapy for the
treatment of adults with previously untreated HER2-positive
metastatic breast cancer (mBC).
HER2-positive cancer is an aggressive form of breast cancer,
which is the most common cancer among women.
The EU's decision was based on positive results from the phase
III CLEOPATRA study. The results demonstrated that 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
The approval does not come as a surprise since in Dec 2012 the
Committee for Medicinal Products for Human Use (CHMP) of the EMA
had recommended the approval of Perjeta for the indication.
We note that the US Food and Drug Administration (FDA)
approved Perjeta plus Herceptin and docetaxel chemotherapy for
treating HER2-positive mBC in patients in Jun 2012.
Roche also received approval for Perjeta in Switzerland and
Mexico in Aug 2012 and Sep 2012, respectively. Moreover, Roche
expects to get Perjeta approved in more countries in 2013.
We remind investors that in Feb 2013, the FDA approved Kadcyla
(ado-trastuzumab emtansine or T-DM1) for the treatment of
patients suffering from HER2-positive mBC.
We believe the approvals of Perjeta and Kadcyla has
strengthened the company's HER2-franchise considerably. Roche
expects Perjeta and Kadcyla to positively impact results in
Roche currently carries a Zacks Rank #4 (Sell). Pharma stocks,
which currently look well placed, include
Shire plc (
). All three stocks carry a Zacks Rank #2 (Buy).
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