FDA Approval of Breakthrough Therapy Designations Continue To Soar
The FDA announces April 29th, the approval of another FDA Breakthrough Therapy Designation (BTD). The accelerated approval is for Novartis’ orphan drug Zykadia (Ceritinib), previously known as LDK378, for patients with metastatic, Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small Cell Lung Cancer (NSCLC), who were previously treated with Pfizer’s orphan drug Xalkori (Crizotinib). Xalkori is the only other FDA approved (2011) ALK+ Tyrosine Kinase Inhibitor (TKI) for metastatic NSCLC.
Zykadia is the 4th drug with a BTD to receive FDA approval. The approval is 4 months ahead of the PDUFA date of August 24, 2014. The FDA granted Zykadia BTD, priority review, and orphan drug designation (September 2013).
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