FDA Grants Frontline Bosutinib Priority Review in CML

August 29, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for bosutinib for the first-line treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). The agency is scheduled to make a final decision by December 2017. According to Pfizer and Avillion, the co-developers of the tyrosine kinase inhibitor (TKI), the European Medicines Agency (EMA) is also reviewing an application for use of … (leggi tutto)