The US Food and Drug Administration has granted an accelerated approval to Novartis for its metastatic lung cancer treatment Zykadia (ceritinib) less than three and a half years after the first patient entered a clinical trial. On April 29, the agency gave Zykadia accelerated approval for patients with non-small cell lung cancer (NSCLC) who have progressed on Pfizer's first-line treatment Xalkori (crizotinib). Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that is intended for the approximately 4% of NSCLC patients who have a chromosomal rearrangement of the ALK gene that renders the tumor dependent on that signaling pathway. Most ALK+ patients initially respond to New York–based Pfizer's c-Met/ALK inhibitor Xalkori, but within a year, the majority progress, owing to drug resistance. Although the Pfizer drug blocks both c-Met and ALK, it more potently inhibits c-Met. By contrast, the new drug from Basel-based Novartis, which differs structurally from Xalkori, is many times more potent against ALK. This allows it to overcome certain secondary mutations in ALK that cause resistance to Xalkori, says Gregory Riely of Memorial Sloan-Kettering Cancer Center in New York. “Zykadia has been very important to show us that these tumors are still ALK-dependent,” says Alice Shaw of Massachusetts General Hospital in Boston.