The US Food and Drug Administration (FDA) granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) Tyrosine Kinase Domain (TKD) activating mutations, as detected by an FDA-authorised test.

This approval expands the existing indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy.

Efficacy was evaluated in patients with locally advanced or metastatic, non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who received sevabertinib in SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multi-cohort clinical trial. HER2 (ERBB2) activating mutations were determined in tumor tissue or plasma by local laboratories prior to enrollment.

The major efficacy outcome measures were confirmed Objective Response Rate (ORR) and Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) using RECIST.

Among 69 patients with locally advanced or metastatic NSCLC with HER2 (ERBB2) TKD activating mutations who had not received prior systemic therapy, the ORR was 75 percent (95 percent CI: 64, 85); 73 percent of responding patients had a DOR of ≥6 months and 38 percent had a DOR of ≥12 months.

The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, Interstitial Lung Disease (ILD)/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.