China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Ameile (almonertinib). The epidermal growth factor receptor (EGFR) inhibitor is now approved to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive non-small cell lung cancer (NSCLC) with no disease progression after platinum-based radical radiotherapy and chemotherapy.
Clinical Trial Basis
The latest approval is based on results from the Phase III POLESTAR (HS-10296-304) study, which demonstrated that Ameile significantly reduced the risk of disease progression by over 80% compared to placebo and markedly prolonged the progression-free survival of patients (mPFS: 3.8 months vs. 3.4 months).
Previous Approvals and Market Presence
Ameile first gained market approval in China in March 2020 for use in T790M-mutated locally advanced or metastatic NSCLC following first-line EGFR-TKI treatment. It received additional approval in December 2021 for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation. Both indications are included in the National Reimbursement Drug List (NRDL).
Pending Regulatory Decisions
Ameile is also awaiting regulatory decisions in China for use as an adjuvant therapy for EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive NSCLC after tumor resection and in combination with pemetrexed plus platinum-based chemotherapy as first-line treatment for locally advanced or metastatic NSCLC in adult patients with the specified mutations.-Fineline Info & Tech
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