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CHMP Positive on Roche's Kadcyla - Analyst Blog
9/23/2013 11:39:00 AM
Roche ( RHHBY ) 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 year end.
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 (mbc).
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 cancer.
The EU approval of the subcutaneous formulation of Herceptin earlier this month was also a boost to Roche's HER2+ franchise.
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 Novartis' ( NVS ) Afinitor is also approved in the U.S. 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). Bayer ( BAYRY ) ALSO looks attractive with a Zacks Rank #2 (Buy).
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