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The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the kinase inhibitor sevabertinib (Hyrnuo) for adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations (gene changes), as detected by an FDA-authorized test.
The approval expands eligibility for sevabertinib to people who haven’t yet received systemic treatment. It gives some people with HER2-mutated advanced NSCLC another targeted treatment option before they’ve received other systemic treatment.
Two to 4 percent of people with NSCLC have HER2 gene mutations. Biomarker testing can help detect mutations in a person’s cancer and match them to available treatments.
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The FDA’s accelerated-approval pathway allows earlier access based on an endpoint that’s reasonably likely to predict clinical benefit. Follow-up studies are required to confirm that benefit.
Sevabertinib is an oral, reversible tyrosine kinase inhibitor. It’s designed to block abnormal signals linked to certain HER2 changes, which may slow the growth of cancer cells.
The new approval is for HER2 TKD activating mutations. That’s different from HER2 amplification or HER2 overexpression, which are other types of HER2 findings. A HER2 mutation is a change in the HER2 gene that can drive cancer growth.
Sevabertinib is typically taken by mouth twice daily with food until the cancer gets worse or side effects become unacceptable.
The FDA based its approval on SOHO-01, an open-label, single-arm, multicenter, phase 1/2 clinical trial. For the expanded approval, the FDA evaluated 69 adults with locally advanced or metastatic NSCLC and HER2 TKD activating mutations who had not received previous systemic treatment.
Key trial findings included the following:
Because the study didn’t compare sevabertinib with another treatment, the results don’t show whether it helps people live longer than other options.
Like all treatments, sevabertinib can cause side effects. The most common side effects listed in the prescribing information include:
It’s important to discuss potential side effects for any treatment with your healthcare provider.
The expanded approval means some people with advanced nonsquamous NSCLC and HER2 TKD activating mutations may be able to consider sevabertinib as an initial systemic treatment option.
Talk with your healthcare provider about your biomarker results, treatment goals, treatment history, and the options that may be appropriate for you.
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