AstraZeneca’s immunotherapy Imfinzi (ingredient: durvalumab) won domestic sales approval Tuesday, as the Ministry of Food and Drug Safety gave the nod to the company’s local offshoot to sell the therapy in Korea.
As an injection inhibiting programmed death-ligand 1(PD-L1), Imfinzi received an indication for locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults, whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).
In the U.S., AstraZeneca obtained the nod for Imfinzi in February as the first immunotherapy to be used for patients with unresectable tumors. The latest local approval gives a treatment option to patients with unresectable NSCLC.
According to the phase-3 PACIFIC trial on Imfinzi, the immunotherapy offered more than 11 months of the median progression-free survival, compared to the placebo. Regardless of PD L-1, Imfinzi reduced the relative risk of disease progression or death by 48 percent in all patients, compared to the placebo.
AstraZeneca Korea is conducting another domestic trial to evaluate Imfinzi’s safety and efficacy in various cancers.
The drugmaker received the ministry’s approval for phase-3 trials for NSCLC, head and neck cancer, small cell lung cancer, and muscle-invasive bladder cancer.