The U.S. Food and Drug Administration had approved Takeda Pharmaceutical Co.’s drug, Exkivity, to treat a particular type of lung cancer, the Japanese pharmaceutical company announced on 15th September.
The drug has been approved only for patients having a particular gene mutation in non-small cell lung cancer (NSCLC) known as EGFR Exon 20 insertion, whose disease has grown during or after the chemotherapy.
Exkivity’s approval from the FDA was explicitly based on some affirmative and meaningful results yielded from early-to-mid stage trials carried out on 114 patients having NSCLC, over a period of 18 months on average, the company said, which is subjected to the verification and description of clinical benefit through confirmatory trials.
However, the drug is marketed with a boxed warning indicating potential risks relating to the heart toxicity, heart rhythm disturbance and lung diseases.
According to the World Health Organization, NSCLC is the most common type of lung cancer constituting up to 85% of the estimated 2.2 million cases of lung cancer diagnosed every year globally.