LUNGevity Foundation applauds the FDA approval of Zykadia™ for the subset of anaplastic lymphoma kinase-positive (ALK+) patients with advanced cases of non-small cell lung cancer who have progressed on or are intolerant to crizotinib. Zykadia™ was given breakthrough therapy designation in March 2013 and received FDA approval under the agency's accelerated approval program. Having a range of ALK inhibitors provides important options for these patients. Zykadia™ approval helps address an unmet medical need. Non-small cell lung cancer is the most common form of lung cancer, representing 85% of lung cancer cases, and in the majority of patients it is diagnosed in locally advanced or metastatic stages when it is more difficult to treat.
"The approval of Zykadia™ is an important milestone in the treatment of lung cancer as it offers the opportunity for patients who are ALK+ to continue to do well once they have progressed on crizotinib," said LUNGevity Foundation President Andrea Stern Ferris. "Several of our constituents participated in the pivotal clinical trial for Zykadia™ and continue to do well today. We applaud the FDA and Novartis for successfully bringing this product to the patients so quickly." LUNGevity Foundation, as the largest private funder of lung cancer research in the United States, places a high priority on lung cancer research that can directly improve patients' lives.
Zykadia™ is an oral, selective inhibitor of ALK, an important therapeutic target in lung cancer. Zykadia™ is one of the first medicines to be approved following FDA Breakthrough Therapy designation, which was received in March 2013 due to the significance of results observed in the pivotal trial and the serious and life-threatening nature of ALK+ NSCLC. "It is exciting to see advancements come to market for this group of patients who respond so well to ALK inhibitors but are in need of follow-on therapies," said Ferris.
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