FDA Approves Roche's Kadcyla - Analyst Blog
February 25 2013 - 11:05AM
Zacks
Roche (RHHBY) 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
emtansine) to GlaxoSmithKline's (GSK) Tykerb
(lapatinib) along with Roche’s Xeloda (capecitabine) in these
patients.
Roche has partnered with ImmunoGen, Inc. (IMGN)
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
(mBC).
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, Bayer (BAYRY), currently
looks attractive with a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
IMMUNOGEN INC (IMGN): Free Stock Analysis Report
ROCHE HLDG LTD (RHHBY): Get Free Report
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