) received positive news when the European Union's (EU) Committee
for Medicinal Products for Human Use (CHMP) recommended the
approval of its breast cancer drug Kadcyla.
A final decision by the European Commission is expected by
The CHMP gave positive opinion on Kadcyla for the treatment of
previously treated adults suffering from HER2+positive,
unresectable locally advanced or metastatic breast cancer
The CHMP positive opinion was based on encouraging data from
the phase III study, EMILIA. Data from the study showed that
Kadcyla helped extend the life expectancy of patients who were
previously treated with Herceptin and a taxane chemotherapy.
Additionally, Kadcyla also showed a tolerable safety profile
with less severe side effects.
Further, Kadcyla was also approved in Japan for the treatment
of HER2+ positive inoperable or recurrent breast cancer.
We note that Roche has a solid position in the breast cancer
market with drugs like Herceptin, Perjeta, and Kadcyla in its
kitty for the treatment of patients suffering from HER2+ breast
The EU approval of the subcutaneous formulation of Herceptin
earlier this month was also a boost to Roche's HER2+
Moreover, the U.S. Food and Drug Administration's (FDA)
Oncologic Drugs Advisory Committee (ODAC) recommended accelerated
approval of Perjeta regimen for neoadjuvant treatment (use before
surgery) in HER2+ early stage breast cancer patients.
The positive opinion on Kadycla and an expected approval by
year end should further strengthen the breast cancer franchise at
Roche which generated sales of CHF 3.3 billion in the first half
of 2013, up 11% year over year.
We note that
) Afinitor is also approved in the U.S. and the EU for the
treatment of HER2+ advanced breast cancer in combination with
) Aromasin in postmenopausal women, whose disease has returned or
progressed even after undergoing treatment with a non-steroidal
Roche currently carries a Zacks Rank #1 (Strong Buy).
) ALSO looks attractive with a Zacks Rank #2 (Buy).
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