U.S. FDA approves Takeda's lung cancer therapy

FILE PHOTO: Takeda Pharmaceutical Co's logo is seen at its new headquarters in Tokyo, Japan, 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 said 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.

(Reporting by Dania Nadeem in Bengaluru; Editing by Shailesh Kuber and Krishna Chandra Eluri)

(c) Copyright Thomson Reuters 2021. Click For Restrictions -
https://agency.reuters.com/en/copyright.html