On October 30, 2023 ArriVent Biopharma, Inc., a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (Press release, ArriVent Biopharma, OCT 30, 2023, https://arrivent.com/arrivent-receives-fda-breakthrough-therapy-designation-for-furmonertinib-for-first-line-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=arrivent-receives-fda-breakthrough-therapy-designation-for-furmonertinib-for-first-line-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations [SID1234636428]).

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"Breakthrough Therapy designation is an important step forward in our development of furmonertinib and highlights its exciting potential as a first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations," said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent.

Stuart Lutzker, Co-founder and President of R&D added: "This FDA designation underscores the encouraging clinical activity we have seen with furmonertinib in the FAVOUR study and reflects the critical need for effective and tolerable therapeutic options for these patients. We look forward to continuing our work with the agency as we progress our furmonertinib clinical development program in NSCLC, including our ongoing pivotal, global Phase 3 FURVENT trial evaluating furmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations."

The Breakthrough Therapy designation was granted based on interim results from FAVOUR trial (NCT04858958), a Phase 1b, randomized, open-label, multi-center clinical trial evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. FDA’s Breakthrough Therapy designation is designed to expedite development and review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies. Interim results from the trial demonstrated furmonertinib has promising anti-tumor activity as a single agent with a well-tolerated safety profile in the first-line and previously treated patients. The pivotal Phase 3 FURVENT trial (NCT05607550) of furmonertinib for the treatment of first-line NSCLC with EGFR exon 20 insertion mutations is currently enrolling patients globally.