Roche (RHHBY) recently received positive news when the U.S. Food and Drug Administration’s (:FDA) Oncologic Drugs Advisory Committee (:ODAC) voted in favor of recommending accelerated approval of Perjeta regimen for neoadjuvant treatment (use before surgery) in HER2+ early stage breast cancer patients.
A final decision from the FDA is expected by Oct 31, 2013.
We note that Perjeta is approved in the U.S. and the EU for the treatment of patients suffering from HER2+ metastatic breast cancer (mbc) in combination with Herceptin.
The ODAC’s recommendation was based on positive results from two phase II studies on Perjeta, NEOSPHERE (Neoadjuvant Study of Pertuzumab and Herceptin in an EarlyRegimen Evaluation) and TRYPHAENA (ToleRabilitY of Pertuzumab, Herceptin and AnthracyclinEs inNeoAdjuvant breast cancer) in patients suffering from HER2+ early stage breast cancer.
The committee, while recommending approval, also evaluated data from a phase III study, CLEOPATRA, in HER2+mbc patients to review the safety profile of Perjeta in the long run.
Meanwhile, another ongoing phase III study, APHINITY, will further evaluate the adjuvant (after surgery) use of Perjeta and compare Perjeta in combination with Herceptin and chemotherapy versus Herceptin along with chemotherapy in patients suffering from HER2+ early stage breast cancer.
The primary endpoint of this study is invasive disease-free survival. The study is fully enrolled with data expected in 2016.
We note that Roche has a solid position in the breast cancer market. Apart from Herceptin and Perjeta, Roche also has drugs like 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 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.
Roche currently carries a Zacks Rank #3 (Hold). Right now, Ironwood Pharmaceuticals (IRWD), Jazz Pharmaceuticals (JAZZ), and Forest Laboratories Inc. (FRX) look attractive, each carrying a Zacks Rank #2 (Buy).