On December 25th, the CDE (Center for Drug Evaluation) website indicated that a new indication for Allist Pharmaceuticals' Furmonertinib is proposed to be included in the Breakthrough Therapy Designation program. The proposed indication is for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations. Furmonertinib is a third-generation EGFR-TKI, which has previously received approval in China for two indications: second-line and first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutations. In July of this year, the marketing application for Furmonertinib's third indication was accepted by the CDE and granted priority review status, intended for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who have progressed on or are intolerant to platinum-based chemotherapy. This latest proposal for breakthrough therapy designation is for a new indication—first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR PACC mutations. EGFR PACC mutations primarily encompass approximately 70 mutation subtypes, accounting for about 12.5% of all EGFR-mutant NSCLC patients. Currently, there are no approved drugs in China specifically for NSCLC patients with EGFR PACC mutations. In the FURMO-002 study, researchers evaluated the preliminary efficacy and safety of Furmonertinib as a first-line treatment for NSCLC patients carrying EGFR PACC mutations. Allist pointed out that the FURMO-002 study is the world's first prospective study conducted on an advanced NSCLC population with various EGFR PACC mutation subtypes. As of June 2025, based on assessments by an Independent Review Committee (BICR) using RECIST v1.1 criteria, the best Objective Response Rate (ORR) for first-line treatment with 240 mg Furmonertinib in advanced NSCLC patients with EGFR PACC mutations was 81.8%, the confirmed ORR was 68.2%, the Disease Control Rate (DCR) was 100%, the median Duration of Response (DOR) was 14.6 months, and the median Progression-Free Survival (PFS) was 16.0 months. Furthermore, Furmonertinib also demonstrated a favorable safety profile in the study. Furmonertinib is the primary revenue source for Allist Pharmaceuticals, and its sales have increased year-over-year since its market launch. In 2024, Furmonertinib generated annual revenue of 3.506 billion yuan, a year-on-year increase of 77.27%. In the first half of 2025, Furmonertinib continued its strong growth trend, achieving product sales revenue of 2.36 billion yuan, a year-on-year increase of nearly 51%. As of the end of 2025, other targeted drugs in China with published evidence-based data and included in the latest guidelines/consensus as "considerable for first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR PACC mutations" include Afatinib from Boehringer Ingelheim, Osimertinib from AstraZeneca, and Dacomitinib from Pfizer.
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