FDA Grants Priority Review to Lorlatinib for ALK+ NSCLC

February 12, 2018 – The FDA has granted a priority review to a new drug application (NDA) for lorlatinib for use in patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on 1 or more ALK tyrosine kinases inhibitors (TKIs). The priority review follows a breakthrough therapy designation awarded in April 2017, and the FDA is now scheduled under the Prescription Drug User Fee Act to make its final decision by August 2018. Pfizer, the … (leggi tutto)