) 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
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,
Forest Laboratories Inc.
) look attractive, each carrying a Zacks Rank #2 (Buy).
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