Alecensa first line – pro
Alecensa was FDA approved SECOND LINE based on the global, randomised phase III ALEX stud.. ALECENSA was indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response.
There are 4 ALK acting agents that are approved and Alocensa is the most recent one that had been studied.A study of it against crizotinib found that it was superior in first line. On October 3, 2016, it received a Breakthrough FDA Indicaiton for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor. This outcome was reported as a late-breaking abstract at the 2017 American Society of Clinical Oncology Annual Meeting.
The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. It is something short of an actual full indication, but suggests a future full approval. Since the ASDOC abstract was postiive, approval is expected.