China’s National Medical Products Administration (NMPA) approves **Zorifer (zorifertinib hydrochloride tablets)** as the first-line treatment for adult patients with **locally advanced or metastatic non-small cell lung cancer (NSCLC)**. The drug targets patients with **EGFR exon 19 deletion or exon 21 L858R substitution mutations** and **central nervous system (CNS) metastases**. Zorifer, previously known as AZD3759, is developed jointly by **AlphaBio Pharma** and **AstraZeneca**.
Nov 2024MedthorityNews article
Alpha Biopharma secures NMPA approval for **Zorifertinib Tablets (Zorifer®)**, the world’s first **EGFR-TKI** specifically for **lung cancer patients with brain metastases**. The drug, classified as a **Class 1 innovative drug**, targets **first-line treatment** of **EGFR-mutant non-small cell lung cancer (NSCLC)**. This marks a milestone in addressing a critical unmet need in oncology.
Nov 2024BioSpaceNews article
Zorifertinib secures NMPA approval as a first-line treatment for patients with EGFR-mutant advanced or metastatic non-small cell lung cancer (NSCLC) that has spread to the central nervous system (CNS). The drug targets EGFR-positive tumors, addressing a critical need for effective therapies in this aggressive cancer subtype. Approval covers use in China’s regulatory framework.
Nov 2024OncLiveNews article
China’s National Medical Products Administration (NMPA) is reviewing the New Drug Application (NDA) for **zorifertinib**, a tyrosine kinase inhibitor developed for patients with **EGFR-mutated non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases**. The **phase 2/3 EVEREST study** demonstrated efficacy and safety comparable to other treatments in this patient group.
Jan 2023Targeted OncologyNews article
