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U.S. FDA approves Takeda’s lung cancer therapy By Reuters

by Mike Robinson

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© Reuters. FILE PHOTO – Takeda Pharmaceutical Co. logo seen at the new Tokyo headquarters on July 2, 2018. REUTERS/Kim Kyung-Hoon

(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.

A boxed warning warns of possible heart disease, heart rhythm disorders and potential heart toxicity.

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