What Is Hyrnuo (Sevabertinib)? FDA Approval, Licensing in Turkey and Reimbursement Status
Reading tools
In this article
Drug Profile
- Brand Name: Hyrnuo®
- Active Ingredient: Sevabertinib
- Class: HER2 (ERBB2) kinase inhibitor; also active against EGFR
- Route of Administration: Oral (Tablet)
- Manufacturer: Bayer HealthCare Pharmaceuticals Inc.
🇹🇷 Status in Turkey (Licensing, Price and SGK)
- Licensing Status: FDA approval does not establish licensing in Turkey. Current licensing status should be verified in TİTCK records.
- SGK Reimbursement: FDA approval does not determine SGK reimbursement. Current coverage should be checked in SGK/SUT records.
- Access and Price: This account based on FDA sources provides no verified current price . Access pathways and pricing in Turkey require separate confirmation through current authorized channels.
What Is Sevabertinib? How Does It Work?
Hyrnuo (Sevabertinib) is a small molecule that reversibly inhibits HER2 kinase. The FDA label also describes activity against EGFR .
🔬 Why Sevabertinib?
- Target and action: In cell studies, it inhibits HER2 phosphorylation and downstream signaling. It also has activity against EGFR; diarrhea and rash are among its common adverse effects.
- Brain metastases: SOHO-01 included patients with treated, stable and asymptomatic brain metastases; patients with symptomatic central nervous system metastases were excluded. These findings do not establish prevention of brain recurrence.
Approved Indications
- Locally Advanced or Metastatic HER2-Mutant Nonsquamous NSCLC: Under the September 2026 FDA label, it is indicated for adults whose tumors have, as detected by an FDA-authorized test, HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. The requirement for previous systemic therapy was removed in the indication expansion of 9 September 2026.
FDA Approval History
📅 19 November 2025: initial accelerated approval; 9 September 2026: indication expansion
The FDA granted accelerated approval on the basis of SOHO-01 (NCT05099172) , an open-label, single-arm, multicenter study, using objective response rate (ORR) and duration of response (DOR) data. Continued approval may depend on confirmation of clinical benefit in a confirmatory trial.
Administration and Dosage
- Standard Dose: Taken orally twice daily with food: 20 mg.
- Administration: Swallow tablets whole; do not cut, crush or chew them. Take with food. Treatment continues until disease progression or unacceptable toxicity.
- Missed or Vomited Dose: Take a missed dose as soon as it is remembered before the next scheduled dose; do not take two doses together to make up for it. If vomiting occurs after a dose, do not take an additional dose; take the next dose at the scheduled time.
Dose Modification and Management
| Adverse-Effect Grade | Action Required |
|---|---|
| 1. Dose Reduction Level | Reduce to 10 mg twice daily. |
| 2. Dose Reduction Level | Reduce to 10 mg once daily. Permanently discontinue treatment if this dose is not tolerated. |
| Adverse-Effect-Specific Dose Decisions | Interruption, dose reduction or permanent discontinuation depends on the type and severity of the adverse effect, following the table in FDA label section 2.3. For example, confirmed ILD/pneumonitis requires permanent discontinuation at any grade; a single rule does not apply to all Grade 3/4 events. |
Adverse Effects
- Gastrointestinal: Diarrhea (which can be severe), nausea, vomiting, stomatitis and decreased appetite.
- Hepatobiliary: Elevated AST and ALT enzymes (changes in liver function).
- Dermatological: Rash, paronychia (inflammation around the nail) and dry skin may occur; rash should not be assumed to be mild.
- Serious Risks: Warnings include ILD/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation and embryo-fetal toxicity. At twice the maximum recommended dose, a mean QTc increase >20 ms was not observed. The label includes ECG QT prolongation within a grouped list of arrhythmias, without assigning it a separate ‘rare’ frequency.
Special Situations and Warnings
- Lung Monitoring: Immediately report new or worsening cough, shortness of breath or fever to the treatment team. Permanently discontinue Hyrnuo if ILD/pneumonitis is confirmed.
- Liver, Heart, Pancreatic and Eye Monitoring: Measure ALT, AST and total bilirubin before treatment, every two weeks during the first month, then monthly and as clinically indicated; test more frequently if transaminases rise. Assess LVEF before treatment and at regular intervals during treatment and as clinically indicated. Monitor amylase and lipase regularly throughout treatment. Immediately report new or worsening eye symptoms to the treatment team; prompt referral to an ophthalmologist is required.
- Avoid Grapefruit: Avoid grapefruit and grapefruit juice during treatment.
- Pregnancy, Contraception and Breastfeeding: Verify pregnancy status before treatment in females of reproductive potential. These females and males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose. Do not breastfeed during treatment or for 1 week after the last dose.
Pharmacokinetics and Interactions
- Half-Life: The effective half-life is approximately 8 hours. The recommended schedule is twice daily.
- Interactions: Sevabertinib is metabolized mainly by CYP3A ; CYP1A1 and glucuronidation contribute to a lesser extent. Avoid strong CYP3A inhibitors; if unavoidable, reduce the dose according to label section 2.4. Monitor adverse effects with moderate inhibitors. Avoid strong or moderate CYP3A inducers. Sevabertinib may also increase exposure to certain CYP3A and P-gp substrates; all concomitant medicines require review by the treating clinician/pharmacist.
Adverse-Effect Management Guide
- Diarrhea Management: At the first sign of diarrhea or increased stool frequency, contact the treatment team, start an antidiarrheal such as loperamide as instructed, and increase fluid and electrolyte intake. Loperamide is not an antidiuretic.
- Skin Care: Alcohol-free, fragrance-free moisturizers and high-SPF sunscreens are recommended.
- Fatigue: Energy should be managed with light exercise and support for good sleep hygiene.
References
- FDA. HYRNUO (sevabertinib) Prescribing Information. Revised September 2026.
- FDA. FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. 19 November 2025.
- FDA. FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer. 9 September 2026.
Was this article helpful?
Your feedback helps us improve our content.
Reader comments
Share your comment
Your name and comment are published only after administrator approval. Your email address is never shown to visitors.
Be the first to comment.