(Reuters) – Takeda Pharmaceutical Co’s lung cancer drug received the recommendation of a European Union panel on Friday, more than a year after it won regulatory approval to be sold in the United States.
The European Medicines Agency’s Committee for Medicinal Products for Human Use, recommended granting Japan-based Takeda’s Alunbrig, or brigatinib, a marketing authorization.
The panel’s recommendations are generally followed by European regulators.
Alunbrig was approved last year by the U.S. Food and Drug Administration as a second-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, who have progressed on or are intolerant to Pfizer drug crizotinib, the standard initial treatment for the disease.
Reporting by Sangameswaran S in Bengaluru; Editing by Sai Sachin Ravikumar