The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
October 15, 2016 – Venetoclax, a drug for patients with an aggressive form of chronic lymphocytic leukemia (CLL), specifically either 17p deletion or TP53 mutation markers has received conditional approval from the European Medicines Agency (EMA).
Typically, patients with these markers have a median life expectancy of less than two to three years. The EMA grants conditional approval for drugs that fill an unmet medical need for serious conditions and show early evidence of clinical benefits outweighing the risks.
Venetoclax, developed by AbbVie and Roche Holding AG, was approved by the U.S. Food and Drug Administration in April to treat the disease. AbbVie will market the drug outside the United States, while both companies will sell it in the country under the brand name Venclexta.
Read more here:
http://dailycommercenews.com/2016/10/15/abbvie-leukemia-drug-receives-conditional-approval-from-ema/
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