16 Sept 2021
FDA Approves Exkivity as First Oral Therapy for Lung Cancer
The Index Today
The Japanese Pharma Company, Takeda Pharmaceutical Co said on Wednesday the U.S. Food and Drug Administration approved its drug, Exkivity, to treat a type of lung cancer.
According to the reports from Reuters, Takeda said that the approval was based on an early-to-mid-stage trial testing 114 patients with non-small cell lung cancer, with results showing clinically meaningful responses with a median duration of about 18 months.
Exkivity was approved for patients with a specific gene mutation called EGFR Exon20 insertions in non-small cell lung cancer, whose disease has progressed on or after chemotherapy.
The company said the approval for the indication was contingent upon verification and description of clinical benefit in a confirmatory trial.
Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.
The drug comes with a boxed warning flagging risks of potential heart toxicity, lung disease and heart rhythm disturbances.