JAPAN – Japanese pharma company Takeda Pharmaceutical has been granted approval for its drug, Exkivity, to treat a type of lung cancer by the U.S. Food and Drug Administration.
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.
The approval happens shortly after the company bagged a deal to supply 150 million doses of the Novavax shot that it will produce to the Japanese government.
Even so, Takeda is embroiled in controversy as the country’s distribution partner of the Moderna vaccine. Over the past two weeks, contaminants have been discovered in Moderna vaccine vials in Japan, forcing the suspension of batches of the shot.
Last week, Moderna identified the foreign material as stainless steel, which likely entered through friction from two pieces of machinery incorrectly installed on a production line. Moderna traced the problem to Rovi Laboratories, the Spanish manufacturer which does fill/finish work for the vaccine.
Other contaminants, such as rubber stopper material, also have been discovered recently in Moderna vials in Japan. This material also could have entered during manufacturing, Takeda said.
By taking control of a large portion of the manufacturing of Novovax’s COVID-19 vaccine, Takeda could build confidence in the shot in Japan, giving it a better chance for widespread adoption.
Novavax had hoped to secure FDA approval for its shot this summer. However, manufacturing and supply issues have pushed its target for regulatory submission from May to the fourth quarter of this year.