|
 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.
[to top of second column] |
 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)
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