Hansoh Pharma's Aumolertinib New Indication for Unresectable Locally Advanced NSCLC Nominated for CDE Priority Review
Hansoh Pharma
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On August 20, the CDE website announced that Hansoh PharmaNew Indication Marketing Application for Aumetinib Mesylate TabletsProposed to be included in the priority review, for the treatment of unresectable locally advanced disease without progression after platinum-based radical chemoradiotherapy.Epidermal Growth Factor Receptor (EGFR) Exon 19 deletion or exon 21 (L858R) Substitution Mutation in Non-Small Cell Lung Cancer (NSCLC) PatientTreatment.
This is the 4th indication marketing application for Aumetinib.Insight database predicts that this application is expected to be approved in the second quarter of 2025.
Screenshot source:CDE Official Website
Ameitinib is a third-generation EGFR-TKI developed by Hansoh Pharma. It has previously been approved for two indications in China: 1) forSecond-line TreatmentPatients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are T790M mutation-positive; 2)First-line treatmentWith EGFR exon 19 deletion or exon 21 (L858R) Positive for substitution mutations, adult patients with locally advanced or metastatic NSCLC.
On July 19 this year,CDE Also Accepted the Third Indication Application for Aumolertinib, for EGFR exon 19 deletion or exon 21 (L858R) Positive NSCLC adult patients with tumor resection for adjuvant treatment. Insight database predicts that this application is also expected to be approved in the second quarter of 2025.
The fourth indication for marketing application of Almonertinib to be included in the CDE’s priority review this time is based on the clinical trial data from the HS-10296-304 study, a randomized, controlled, double-blind Phase III clinical trial.CTR20210297), aimed to evaluate the efficacy of Ameitinib Mesylate compared with placebo in patients with unresectable disease who did not experience disease progression after platinum-based radical radiotherapy and chemotherapy.LocalAdvanced EGFR Exon 19 Deletion or Exon 21 (L858R) NSCLC patients with substitution mutationsEfficacy and Safety of Treatment.
The primary endpoint of this trial was progression-free survival (PFS) assessed by an independent review committee.PFS); The secondary endpoint was overall survival (OS), as assessed by the Independent Review Committee (CNSCNS) Time to progression, time to death or distant metastasis (TTDM), Objective Response Rate (ORR), Disease Control Rate (DCR), duration of relief (DoR) and safety, etc.
Hansoh Pharma has not yet disclosed the specific clinical trial data of this study.
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