The approval was based on the results from a phase 1/2 clinical trial which showed EXKIVITY’s clinical benefit and durable responses in the EGFR Exon20 Insertion+ NSCLC patient population
Takeda gets Chinese approval for EXKIVITY in certain patient population with NSCLC. (Credit: J o from Wikimedia Commons)
Takeda has secured approval for EXKIVITY (mobocertinib) from the National Medical Products Administration (NMPA) of China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients.
The approval for the oral tyrosine kinase inhibitor (TKI) is for NSCLC patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose cancer has advanced on or after they received platinum-based chemotherapy.
EXKIVITY is claimed as the first and only therapy available for this patient population in China.
The drug is designed to preferentially target EGFR Exon20 insertion mutations.
It was reviewed in China as part of the NMPA’s Breakthrough Therapy programme. Full approval of the drug for the intended indication is subject to clinical benefit verification in a confirmatory trial.
Takeda global medical affairs oncology head Awny Farajallah said: “The approval of EXKIVITY in China for patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC was only possible through dedicated collaboration and support from the NMPA and the Chinese government.
“Lung cancer is a devastating disease, and we know the discovery and delivery of precision medicines like EXKIVITY to target cancer types that are hard-to-treat have the potential to improve patient outcomes.
“We are thrilled to introduce EXKIVITY in China as the second lung cancer therapy from Takeda and remain committed to research and development to meet the needs of this patient community.”
The approval was backed by the results from a phase 1/2 clinical trial of the oral tyrosine kinase inhibitor in 114 patients having EGFR Exon20 insertion+ NSCLC. The participating patients received prior platinum-based therapy and were given the 160 mg dose of EXKIVITY, the Japanese pharmaceutical firm added.
The results showed a verified overall response rate (ORR) of 28% and a median duration of response (DoR) of 15.8 months for the investigational drug.
Currently, EXKIVITY is also approved in the US, the UK, Switzerland, Australia, and South Korea.