publication date: Sep. 11, 2015

FDA Grants Priority Review to Alectinib in Lung Cancer 


FDA granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

Alectinib, sponsored by Genentech, was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

The New Drug Application for alectinib includes data from two phase II studies, and the FDA will make a decision on approval by March 4, 2016.

ALEX, an ongoing, global randomized phase III study, is comparing alectinib to crizotinib as an initial treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion immunohistochemistry test developed by Roche Diagnostics.

Results from the two phase II studies, NP28761 and NP28673, were recently presented at the 2015 Annual Meeting of the American Society of Clinical Oncology.


Janssen Biotech Inc. announced an exclusive, worldwide license agreement with Alligator Bioscience AB for ADC-1013, an immuno-oncology agent currently in phase I clinical studies.

Under terms of the agreement, Janssen will attain rights to develop and commercialize ADC-1013, an agonistic fully human monoclonal antibody. ADC-1013 targets CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulating this receptor initiates a process leading to an increase in T cells attacking a tumor.

Alligator Bioscience will receive … Continue reading 41-33 FDA Grants Priority Review to Alectinib in Lung Cancer

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