logo
Plus   Neg
Share
Email

EC Approves Marketing Authorization Of DACOGEN For Acute Myeloid Leukemia

Astex Pharmaceuticals Inc. (ASTX) said that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for DACOGEN for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukemia or AML, according to the World Health Organization classification, who are not candidates for standard induction chemotherapy. Also, DACOGEN has been granted Orphan Drug designation to treat AML.

The data in support of the marketing authorization is based on the Phase 3 DACO-016 study that compared decitabine to patients' choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML.

DACO-016 was a Phase 3, randomized, open-label trial, in newly diagnosed patients =65 years of age with de novo or secondary AML and poor- or intermediate-risk cytogenetics.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
McDonald's Corp. has announced the return of its popular Shamrock Shake milkshake for a limited time at participating U.S. restaurants nationwide. The minty green milkshake is made with McDonald's vanilla soft serve blended with Shamrock Shake syrup and topped with whipped topping. It first debuted on the McDonald's menu in 1970 and has been a seasonal tradition for nearly 50 years. Asia-focused lender HSBC, through its blockchain-powered platform, has reduced the cost of settling foreign exchange trades by 25 percent, Reuters reported quoting a bank executive overseeing the project. Mark Williamson, chief operating officer of FX cash trading and risk management, told that the bank processes between 3,500 and 5,000 trades a day on its "FX Everywhere" system. PepsiCo, Inc. (PEP) reported fourth-quarter core EPS of $1.49 compared to $1.31, prior year. Excluding the impact of foreign exchange translation, core constant currency EPS increased 17 percent year-over-year. On average, 19 analysts polled by Thomson Reuters expected the company to report profit per...
Follow RTT