The breakthrough therapy designation is intended for the treatment of patients diagnosed with previously untreated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations
The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD. (Credit: The U.S. Food and Drug Administration/ Wikipedia)
ArriVent Biopharma has reported that the US Food and Drug Administration (FDA) has awarded breakthrough therapy designation for furmonertinib.
The breakthrough therapy designation is intended for the treatment of patients diagnosed with previously untreated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) characterised by epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
It signifies the FDA’s recognition of the drug’s potential to address a critical medical need and accelerate its development and review for this specific patient population.
ArriVent chairman, co-founder and CEO Bing Yao said: “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.”
ArriVent co-founder and R&D president Stuart Lutzker said: “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 tumours contain EGFR exon 20 insertion mutations.”
The Breakthrough Therapy designation was granted on the basis of interim findings from the FAVOUR trial (NCT04858958), which is a Phase 1b, randomised, open-label, multi-centre clinical study designed to assess the efficacy and safety of furmonertinib in patients diagnosed with locally advanced or metastatic NSCLC featuring EGFR exon 20 insertion mutations.
The FDA’s Breakthrough Therapy designation aims to expedite the development and review of drugs intended for the treatment of severe or life-threatening conditions when initial clinical evidence suggests that the drug could bring substantial improvements over existing therapies.
The interim results from the trial indicated that furmonertinib exhibits promising anti-tumour activity as a standalone treatment and has a well-tolerated safety profile in both first-line and previously treated patients.
Additionally, the pivotal Phase 3 FURVENT trial (NCT05607550) for furmonertinib’s use in treating first-line NSCLC with EGFR exon 20 insertion mutations is presently enrolling patients on a global scale. This trial represents a critical step in evaluating the drug’s effectiveness and safety for this patient population.
Furmonertinib is an innovative, orally administered EGFR kinase inhibitor that possesses excellent brain penetration capabilities. It is engineered for broad-spectrum activity and selectivity across a range of EGFR mutations. This includes not only classical EGFR mutations like exon 19 deletion and L858R but also less common EGFR mutations such as exon 20 insertion mutations.
The development of furmonertinib is a collaborative effort, with Allist Pharmaceuticals overseeing its development in China, while ArriVent Biopharma is responsible for its development in the rest of the world. This promising drug offers a potential therapeutic solution for a broad spectrum of EGFR mutations in the treatment of non-small cell lung cancer.