LOGO
LOGO

Quick Facts

EC Approves Marketing Authorization Of DACOGEN For Acute Myeloid Leukemia

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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

Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.