Therapy Areas: Central Nervous System
Chinese regulator accepts Alpha Biopharma's Zorifertinib New Drug Application
30 January 2023 -

Alpha Biopharma, a China-based developer of innovative drugs, announced on Sunday that the company's New Drug Application (NDA) for Zorifertinib, a next-generation EGFR-TKI, has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), China's drug regulator.

Zorifertinib is intended to treat advanced EGFR-mutated non-small cell lung cancer (NSCLC) subjects with central nervous system (CNS) metastases. It is the first EGFR-TKI to be tested in a prospective, controlled registration clinical study for this difficult-to-treat patient population. If the product receives approval, then it will bring a much-needed new treatment option for these subjects.

The EVEREST study was a multinational, multicentre, randomised, open-label, controlled phase II/III clinical trial designed to evaluate the efficacy and safety of Zorifertinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with CNS metastases. The study was carried out in 55 study sites located in the Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrolment of 492 patients. The last patient last visit (LPLV) of the EVEREST study was completed in the third quarter of 2022. Results from the EVEREST study demonstrated that Zorifertinib effectively reduced the risk of disease progression and patient deaths in the target patient population and showed significant efficacy in treating metastatic lesions in the CNS. In addition, Zorifertinib's safety profile is comparable to other approved EGFR-TKI's. The primary resistance mutation at the time of disease progression is the EGFR T790M mutation.

Professor Yilong Wu, president of the Chinese Thoracic Oncology Group (CTONG) and the leading principal investigator (PI) of the EVEREST study, said, 'Clinical results from this high-quality, controlled study demonstrated that Zorifertinib provided consistent and statistically significant benefits to EGFR-mutated NSCLC patients with different levels of CNS metastasis. It could provide a much-needed new treatment option for these difficult-to-treat patients. The development of Zorifertinib represents a great example of a patient-centric, targeted precision approach to address unmet medical needs.'