The anaplastic lymphoma kinase (ALK) gene was discovered (SJ-93-0002) in the 1990s by St. Jude scientists searching for genes affected by a chromosomal change common in the cancer cells of pediatric patients with anaplastic large cell lymphoma (ALCL). This discovery led to issued patents that were licensed to develop therapeutics for treatment of adult lung cancers. Three ALK inhibitor drugs have been approved by the US Food and Drug Administration (FDA) to treat over 200,000 new cases of lung cancer are diagnosed in the U.S. each year. Current estimates are approximately 3-5% (6,500 to 11,000) patients with non-small cell lung cancer carry the ALK rearrangement and may be candidates for treatment with the drugs:
- Xalkori® (crizotinib) is a FDA approved drug (8/2011) made by Pfizer for use with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
- Zykadia™ (ceritinib) is a FDA approved drug (4/2014) made by Novartis for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib1. The approval of Zykadia addresses an unmet medical need for patients with this type of lung cancer who have progressed on prior therapy.
- Alunbrig™ (brigatinib) is a FDA approved drug (4/2017) made by Takeda (developed by Ariad, which was acquired by Takeda in 2017) as a potent dual inhibitor of ALK and epidermal growth factor receptor (EGFR). It could also overcome resistance to osimertinib in certain patients.