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Label Expansion for Roche's Perjeta

Zacks Equity Research

Roche (RHHBY) continues to strengthen its dominant position in breast cancer field with uptake in new drugs like Perjeta and Kadcyla.

The U.S. Food and Drug Administration (:FDA) recently granted accelerated approval to Perjeta regimen for neoadjuvant treatment (use before surgery) for the treatment of patients suffering from HER2+ early stage breast cancer.

We note that the approval was on the cards as the FDA’s Oncologic Drugs Advisory Committee (:ODAC) voted in favor of recommending accelerated approval of Perjeta for the above mentioned indication in Sep 2013.

The approval was based on positive data from a phase II study, NEOSPHERE (Neoadjuvant Study of Pertuzumab and Herceptin in an EarlyRegimen Evaluation). The study showed that approximately 40% of patients receiving the combination of Perjeta, Herceptin and docetaxel chemotherapy did not have any evidence of tumor tissue detectable at the time of surgery.

The approval was granted under the FDA’s accelerated approval program, which allows conditional approval of a drug for a life-threatening disease based on early evidence suggesting clinical benefit.

The neoadjuvant indication for Perjeta has been approved for use in combination with Herceptin and docetaxel chemotherapy to treat patients suffering from HER2+, locally advanced, inflammatory, or early stage breast cancer.

Additional data from another phase II study, TRYPHAENA  (ToleRabilitY of Pertuzumab, Herceptin and AnthracyclinEs in NeoAdjuvant breast cancer) along with data from a phase III study, CLEOPATRA, supported the approval.

Meanwhile, a full approval will require a complete review of data from the ongoing phase III study, APHINITY. The study is evaluating Perjeta, Herceptin and chemotherapy in comparison to Herceptin and chemotherapy for adjuvant (post-surgery) in people with HER2+ early stage breast cancer. Data is expected in 2016.

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.

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 Roche’s efforts to strengthen its franchise further.

Roche currently carries a Zacks Rank #1 (Strong Buy). Right now, Novo Nordisk (NVO), Jazz Pharmaceuticals (JAZZ), and Cempra, Inc. (CEMP) look attractive. All three carry a Zacks Rank #2 (Buy).

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