U.S. FDA approves Takeda’s lung cancer therapy By Reuters
(Reuters) -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.
Takeda explained that approval was granted based on a mid-stage to early-stage clinical trial that involved 114 patients suffering from non-small-cell lung carcinoma. Results showed clinically significant responses, lasting an average of around 18 months.
For patients suffering from a certain gene mutation (EGFR Exon20 insertions) in non-small cells lung cancer, Exkivity has been approved.
According to the company, approval of the indication is contingent on the confirmation and presentation of clinical benefits in a confirmed trial.
The most common type of lung cancer and the reason for around 85% of new cases each year, is non-small-cell lung cancer. This, according to World Health Organization.
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