) recently announced that the US Food and Drug Administration
(FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1)
for the treatment of patients suffering from HER2-positive
metastatic breast cancer (mBC).
These patients were previously treated with Herceptin
(trastuzumab) and taxane chemotherapy.
The approval was based on positive results from a phase III
study (EMILIA: N=991). The study compared Kadcyla (trastuzumab
) Tykerb (lapatinib) along with Roche's Xeloda (capecitabine) in
Roche has partnered with
) for Kadcyla. We note that Roche filed a New Drug Application
(NDA) for Kadcyla in Jan 2013 after being granted a priority
review in the US in Nov 2012.
In Aug 2012, Roche had filed a Biologics License Application
(BLA) for Kadcyla for the treatment of HER2-positive unresectable
locally advanced or metastatic breast cancer patients.
Roche also submitted a marketing authorization application for
Kadcyla to the European Medicines Agency (EMA) for use in
treatment-experienced HER2-positive metastatic breast cancer
patients. The application is currently under review.
Meanwhile, in Dec 2012, the European Union's Committee for
Medicinal Products for Human Use (CHMP) gave a positive
recommendation for Perjeta (pertuzumab) plus Herceptin
(trastuzumab) and docetaxel to treat patients with HER2-positive
metastatic or locally recurrent unresectable breast cancer
The approval of Kadcyla will strengthen Roche's HER2
franchise. Roche expects Perjeta, Kadcyla and Actemra to
positively impact results in 2013.
Roche currently carries a Zacks Rank #4 (Sell). Another
large-cap pharma stock,
), currently looks attractive with a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
GLAXOSMITHKLINE (GSK): Free Stock Analysis
IMMUNOGEN INC (IMGN): Free Stock Analysis
ROCHE HLDG LTD (RHHBY): Get Free Report
To read this article on Zacks.com click here.