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?() and its partner, Basel-based drug maker Roche Holding, Monday announced that phase III trials of breast cancer drug trastuzumab emtansine (T-DM1) have met the overall survival endpoint.
The company said that updated results from the EMILIA Phase III trial show that patients treated with T-DM1 ?had a significant improvement? in overall survival.?
Shares of the company rose over five per cent on the news, trading at $14.57 as at about 10 a.m. ET.
also said that Genentech, part of the Roche group, has submitted a biologics license application (BLA) for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA), and that Roche expects to soon submit a marketing authorization application (MAA) to the European Medicines Agency.
?It?s impressive that the overall survival endpoint has already been met ? this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities,? said president and CEO Daniel Junius.
?We developed our [Targeted Antibody Payload] TAP technology to achieve more effective, better tolerated anticancer therapies, and are delighted that people treated with trastuzumab emtansine survived significantly longer than those who received a standard therapy.?
The phase III trial was designed to evaluate trastuzumab emtansine for the treatment of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin) and a taxane.?
The company noted that patients enrolled were randomized to treatment with trastuzumab emtansine ? used alone ? or with lapatinib (Tykerb) plus capecitabine (Xeloda), standard-of-care in this setting.
said the first results were reported at the American Society of Clinical Oncology (ASCO) annual meeting in June 2012, which noted that trastuzumab emtansine significantly improved progression-free survival (PFS) compared to standard-of-care therapy and that fewer of the trastuzumab emtansine-treated patients experienced severe adverse events.?
Roche has phase III trials underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic HER2-positive breast cancer.?
Additionally, it plans to initiate registration trials beginning in 2013 to evaluate the compound for three settings in earlier-stage disease.
?We look forward to working with regulatory authorities in the hope of bringing another potential treatment option to people with HER2-positive metastatic breast cancer,? said Roche?s Genentech unit chief medical officer and head of global product development, Hal Barron.
?develops targeted anticancer therapeutics using its expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents and engineered linkers.?
The company said T-DM1 utilizes TAP technology with the trastuzumab antibody and is in global development by Roche under an agreement between and Genentech.
's?TAP technology uses monoclonal antibodies to deliver one of the company?s proprietary cancer-killing agents specifically to tumor cells.?
There are now ten TAP compounds in clinical development, of which three are wholly owned by .
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