Roche's Cancer Drug Moves Forward - Analyst Blog
March 30 2012 - 5:15AM
Zacks
Roche Holdings Ltd. (RHHBY) reported positive
top-line data on trastuzumab emtansine (T-DM1) from a late-stage
trial (EMILIA) conducted in patients suffering from HER2-positive
metastatic breast cancer, who had been treated with Herceptin
(trastuzumab) and taxane chemotherapy. The phase III trial compared
patients treated with trastuzumab emtansine to those treated with
GlaxoSmithKline’s (GSK) lapatinib plus Xeloda
(capecitabine).
The trial results demonstrated that patients dosed with
trastuzumab emtansine experienced a significantly longer
progression free survival, compared to those who were dosed
lapatinib and Xeloda. Additionally, the safety profile of the drug
was consistent with previously-conducted studies.
We note that on the basis of the EMILIA study results, Roche
plans to file for approval in the US and European Union (EU) in
2012 for the treatment of HER2-positive metastatic breast
cancer.
We remind investors that in August 2010, the US Food and Drug
Administration (FDA) had refused to accept Roche’s Biologics
License Application (BLA) seeking accelerated approval for
trastuzumab emtansine as a treatment for breast cancer.
The BLA was submitted by Roche in July 2010 on the basis of
mid-stage trial results. The data demonstrated that the candidate
reduced the size of tumors in one third of patients with advanced
HER2-positive breast cancer.
The regulatory body had not accepted the BLA because it believed
that the patients in the phase II study had not tried all possible
medications available for the treatment of metastatic breast
cancer.
Roche has an agreement with ImmunoGen Inc.
(IMGN) for the global development of trastuzumab emtansine.
We currently have a Zacks #4 Rank (short-term Sell rating) on
Roche.
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