The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Previously approved in China in June 2023 for the treatment of ALK-positive patients with locally advanced or metastatic NSCLC who have experienced disease progression after crizotinib treatment or are intolerant to crizotinib, Iruplinalkib is an ALK inhibitor that has now expanded its therapeutic potential in the country.
The latest approval comes on the heels of the randomized, open, multi-center Phase III INSPIRE study’s first interim analysis, which demonstrated a 27.7 months progression-free survival (PFS), a 0.34 PFS hazard ratio (HR), and a 66% reduction in disease progression or death, reinforcing the drug’s efficacy and safety profile in this patient population.
