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Encouraging Data on Roche's Kadcyla - Analyst Blog
9/30/2013 11:41:00 AM
Roche ( RHHBY ) 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 Kadcyla.
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 taxane chemotherapy.
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 cancer.
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 Novartis ' ( NVS ) Afinitor is also approved in the US and the EU for the treatment of HER2+ advanced breast cancer in combination with Pfizer's ( PFE ) Aromasin in postmenopausal women, whose disease has returned or progressed even after undergoing treatment with a non-steroidal aromatase inhibitor.
Roche currently carries a Zacks Rank #1 (Strong Buy). Right now, Bayer ( BAYRY ) looks attractive with a Zacks Rank #2 (Buy).
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