) 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
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
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
) look attractive. All three carry a Zacks Rank #2 (Buy).
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