EMA gives conditional approval to AbbVie’s cancer drug
An advisory committee of the European Medicines Agency (EMA) on Friday gave its conditional backing to AbbVie Inc.’s venclyxto, a drug developed to treat a form of blood cancer.
Venclyxto, which is also called venetoclax, has been developed to treat chronic lymphocytic leukemia (CLL) by either 17p gene deletion or TP53 mutation. The 17p gene and TP53 mutation are markers for a specifically aggressive form of the deadly disease.
According to AbbVie, patients with 17p gene and TP53 mutation have a median life expectancy of less than 2 to 3 years.
The EMA granted its conditional approval for the drug after a research showed early indication of clinical advantages outweighing potential risks.
AbbVie developed venclyxto in partnership with Roche Holding AG. The U.S. Food & Drug Administration (FDA) approved the drug in April this year.
Chicago-based AbbVie has for some time been increasing its focus on cancer treatments as it is looking to decrease its dependence on Humira, the world’s top-selling drug for arthritis. As part of the same strategy, it acquired Stemcentrx and its experimental lung cancer treatment for $5.8 billion.