News|Articles|September 9, 2026

FDA Grants Accelerated Approval to Hyrnuo for Certain Patients With HER2-Mutated NSCLC

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Key Takeaways

Accelerated approval expands sevabertinib eligibility to systemic therapy–naïve, advanced non-squamous NSCLC with activating HER2 TKD mutations, reinforcing this subset as an actionable molecular cohort.
SOHO-01 demonstrated a 75% ORR, with durable responses in many patients, including 73% lasting ≥6 months and 38% lasting ≥12 months among responders.
Biomarker selection is mandatory, as the indication is restricted to HER2 (ERBB2) TKD activating mutations, underscoring comprehensive molecular profiling in advanced NSCLC workflows.
Safety monitoring should anticipate gastrointestinal, hepatic, pulmonary (ILD/pneumonitis), cardiac (left ventricular dysfunction), ocular, pancreatic laboratory, and reproductive risks outlined in warnings/precautions.
Confirmatory trials are required under the accelerated approval framework to validate clinical benefit, with potential regulatory consequences if benefit is not verified.

FDA grants accelerated approval to Hyrnuo (sevabertinib) for certain patients with HER2-mutated, advanced or metastatic non-small cell lung cancer.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have specific activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.

The approval, granted Sept. 9, 2026, expands the existing indication for Hyrnuo. Previously, the treatment was approved for patients with these HER2 mutations who had already received prior systemic therapy. The expanded approval allows Hyrnuo to be used in patients who have not previously received systemic treatment.

HER2 mutations are genetic changes that can help cancer cells grow. Testing can determine whether a patient's tumor has an activating HER2 TKD mutation and whether a targeted treatment such as Hyrnuo may be an option.

What Did SOHO-01 Show?

The FDA's decision was based on results from the SOHO-01 clinical trial (NCT05099172), an open-label, single-arm, multicenter study.

The trial included 69 patients with locally advanced or metastatic non-squamous NSCLC with HER2 TKD activating mutations who had not previously received systemic therapy.

Researchers evaluated the objective response rate (ORR), which measures how many patients experienced a reduction in the size of their tumors, as well as the duration of response (DOR).

Among the 69 patients:

75% had an objective response to Hyrnuo.
73% of patients who responded maintained their response for at least 6 months.
38% of responding patients maintained their response for at least 12 months.

These results show that Hyrnuo was able to shrink tumors in a significant proportion of patients with HER2-mutated NSCLC, with some responses lasting a year or longer.

How Does Hyrnuo Work?

Hyrnuo (sevabertinib) is a kinase inhibitor, a type of targeted therapy that blocks signals involved in cancer cell growth.

For patients whose tumors have specific HER2 mutations, targeting these altered proteins may help slow or stop the growth of cancer cells.

Because this approval is specifically for tumors with HER2 TKD activating mutations, testing is needed to determine whether a patient's cancer has the mutation identified in the FDA approval.

What Are the Potential Side Effects?

The prescribing information for Hyrnuo includes warnings and precautions for:

Diarrhea
Liver toxicity
Interstitial lung disease (ILD) or pneumonitis
Left ventricular dysfunction
Ocular toxicity
Pancreatic enzyme elevation
Embryo-fetal toxicity

Patients should talk with their health care team about potential side effects and any monitoring that may be needed during treatment.

How Is Hyrnuo Given?

The recommended dose of Hyrnuo is 20 milligrams taken by mouth twice a day with food.

Treatment is continued until the cancer progresses or side effects become unacceptable.

What Does Accelerated Approval Mean?

Hyrnuo received accelerated approval, an FDA pathway that allows certain treatments for serious conditions to become available based on early evidence that they may provide a meaningful benefit.

As part of this pathway, additional studies are required to confirm the treatment's clinical benefit. If a required study does not confirm the expected benefit, the FDA may take regulatory action.

What This Approval Could Mean for Patients

The expanded approval of Hyrnuo gives some people with locally advanced or metastatic non-squamous NSCLC another targeted treatment option, including patients who have not previously received systemic therapy.

The approval also highlights the importance of biomarker testing in lung cancer. Identifying genetic changes such as HER2 mutations can help doctors determine which targeted treatments may be appropriate.

Patients with advanced NSCLC should talk with their oncology team about molecular testing and whether their tumor has biomarkers that could help guide treatment decisions.

Reference

U.S. Food and Drug Administration. “FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer.” September 9, 2026.

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