The US Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo), extending its use to adult patients with locally advanced or metastatic nonsquamous non–small cell lung cancer with activating HER2 tyrosine kinase domain mutations identified by a FDA-authorized test, according to an agency press release.
The approval expanded the existing indication for sevabertinib, a kinase inhibitor. The drug previously received accelerated approval for adult patients with locally advanced or metastatic nonsquamous non–small cell lung cancer with activating HER2 tyrosine kinase domain mutations who had received prior systemic therapy.
Efficacy was evaluated in SOHO-01, an open-label, single-arm, multicenter, multicohort clinical trial of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer with activating HER2 tyrosine kinase domain mutations who received sevabertinib. Local laboratories identified the mutations in tumor tissue or plasma prior to enrollment.
Confirmed objective response rate and duration of response served as the major efficacy outcomes, with both assessed by blinded independent central review using RECIST version 1.1.
Among 69 patients who had not received prior systemic therapy, the objective response rate was 75%. Among responding patients, 73% had a response lasting at least 6 months and 38% had a response lasting at least 12 months.
The recommended dose is 20 mg orally twice daily with food until disease progression or unacceptable toxicity. The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease or pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.
The FDA conducted the review under Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology drugs among international partners. The FDA worked with the United Kingdom’s Medicines and Healthcare products Regulatory Agency on the review. Reviews remained ongoing at the other regulatory agencies.
The application received priority review. The FDA granted sevabertinib breakthrough therapy and orphan drug designations.
Source: US Food and Drug Administration
