Alpha Biopharma Reports the NMPA Acceptance of NDA for Zorifertinib to Treat EGFR-Mutated NSCLC with CNS Metastases

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The NMPA has accepted the NDA for Zorifertinib to treat patients with advanced EGFR-mutated NSCLC with CNS metastases
The P-II/III study (EVEREST) evaluating the efficacy and safety of Zorifertinib in 492 patients at 55 study sites in the Chinese mainland, Taiwan, South Korea & Singapore. The results showed that Zorifertinib effectively reduces the risk of disease progression and patient deaths in the target patient population and also showed significant efficacy in treating metastatic lesions in the CNS
The safety profile was comparable to other approved EGFR-TKIs. Zorifertinib is a potent, oral, reversible inhibitor of mutated EGFR

Ref: PRNewswire | Image: Alpha Biopharma

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