HYRNUO (Sevabertinib)

HYRNUO (sevabertinib), from Bayer, is an oral, reversible HER2 tyrosine kinase inhibitor for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumours carry HER2 (ERBB2) tyrosine kinase domain activating mutations, detected by an FDA-authorised test. The FDA first approved it in November 2025 for previously treated patients and in September 2026 broadened the label to include patients who have not received prior systemic therapy.

In the SOHO-01 study, the confirmed response rate was 75% in 69 patients without prior systemic therapy, with 73% of responses lasting at least 6 months. The recommended dose is 20 mg (two 10 mg tablets) twice daily with food.

• Diarrhoea is common; antidiarrhoeal treatment and fluids should be started at the first sign.
• Liver toxicity, interstitial lung disease/pneumonitis, left ventricular dysfunction, eye toxicity and raised pancreatic enzymes can occur — liver tests, LVEF, amylase and lipase require monitoring.
• HYRNUO can harm an unborn baby. Common side effects include diarrhoea, rash, paronychia, nausea, vomiting and stomatitis. This is an accelerated approval.

Can HYRNUO be imported to India?

Yes. For a patient whose lung cancer carries a HER2 tyrosine kinase domain mutation, HYRNUO can be imported in the patient’s name under the named-patient route on the oncologist’s prescription.

How many tablets does one bottle hold?

In the US, HYRNUO 10 mg tablets come in bottles of 120. At the recommended dose of 20 mg (two tablets) twice a day, that is four tablets a day, so one bottle lasts 30 days.

What documents do we need?

• A prescription from a medical oncologist stating the dose
• Histopathology confirming non-squamous NSCLC and a report showing a HER2 (ERBB2) tyrosine kinase domain mutation
• Government-issued photo ID of the patient (or the hospital’s details for hospital orders)

We confirm the order only after the prescription or requisition has been checked.

How is HYRNUO stored?

The US label asks for storage at 20–25 °C, with short excursions between 15 and 30 °C allowed.

Most patients need HYRNUO every month, so we can plan regular monthly supplies once the first order is confirmed. IPN sources it through authorised distribution channels.

For HYRNUO price in India and delivery time, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA accelerated approval in November 2025 (previously treated patients); extended on 9 September 2026 to patients without prior systemic therapy.
• Japan: Approved on 24 August 2026 for unresectable advanced or recurrent HER2-mutant NSCLC.

Sources:

• HYRNUO US Prescribing Information on DailyMed (revised 9/2026)
• Bayer: FDA accelerated approval of HYRNUO as first-line therapy (September 2026)

Information last checked: October 2026.

What is HYRNUO indicated for?

It is an oral HER2 tyrosine kinase inhibitor, prescribed for HER2-mutant non-squamous non-small cell lung cancer.

Which company makes HYRNUO?

Bayer.

What is the mechanism of HYRNUO?

Sevabertinib is a reversible kinase inhibitor of HER2 (it also has some activity against EGFR). It blocks HER2 signalling that drives the growth of cancer cells carrying HER2 mutations.

Is HYRNUO for HER2-positive (amplified) lung cancer?

It is approved for tumours with HER2 tyrosine kinase domain activating mutations, which is different from HER2 overexpression or amplification.

Should HYRNUO be taken with food?

Yes. The recommended dose is 20 mg twice daily with food.

Does HYRNUO have FDA approval?

Yes. The FDA granted accelerated approval in November 2025.