) released encouraging data on breast cancer drug, Kadcyla, from
a phase III study, TH3RESA.
The results from the study showed Kadcyla was significantly
effective in extending the life span of patients suffering from
advanced HER2+ breast cancer (metastatic and unresectable locally
advanced/recurrent) compared to other treatments .
The data from the trial also showed that the risk of disease
worsening or death was reduced by 47% in patients treated with
We remind investors that Kadcyla was approved in the U.S. in
Feb 2013 for the treatment of people with HER2+ metastatic breast
cancer who have received prior treatment with Herceptin and a
Earlier this month, the European Union's (EU) Committee for
Medicinal Products for Human Use (CHMP) gave positive opinion on
Kadcyla and recommended its approval. A final decision is
expected by year end.
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.
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
We are encouraged by the recent bout of positive news on
Roche's Kadcyla. We believe positive opinion on Kadycla and an
expected approval by year end will 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 US 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). Right
) looks attractive with a Zacks Rank #2 (Buy).
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