New Pill for a Gene-Related Advanced Lung Cancer

Hyrnuo (sevabertinib; pronounced Her noo' oh) is an oral, reversible HER2 tyrosine-kinase inhibitor. It is not a HER2 antibody and it is not for “HER2-positive” lung cancer in the breast-cancer IHC sense. The labelled molecular class in the United States and Canada is a HER2 (ERBB2) tyrosine kinase domain activating mutation — most often an exon 20 insertion such as YVMA.

The United States Food and Drug Administration (FDA) granted accelerated approval on 19 November 2025, for use after earlier treatment. On 9 September 2026, it widened that accelerated approval to include first treatment. Health Canada issued a Notice of Compliance with Conditions on 29 January 2026; Bayer notified first sale on 24 April 2026. The UK MHRA granted a marketing authorisation to Bayer PLC on 1 April 2026. Japan’s MHLW approved ヒアニュオ on 24 August 2026 for HER2 mutation-positive unresectable advanced or recurrent NSCLC, without a prior-therapy restriction in the PMDA table. China’s NMPA approval is a company announcement until nmpa.gov.cn is retrieved.

Since 9 September 2026, the United States label no longer requires earlier drug treatment; this use is also under accelerated approval. The Canadian label is still after prior systemic therapy. Japan’s first-line wording does not change the Canadian label.

This is not a cure. Accelerated approval means the United States approval rests on early results: how many tumours shrank, and for how long. Continued approval depends on a confirmatory trial. The approval letter names it: SOHO-02 must “verify and describe the clinical benefit” in people with no prior therapy for advanced disease. The approval letter lists trial completion in April 2029 and a final report in October 2029. If it does not confirm a benefit, the FDA may withdraw the approval. Canada’s NOC/c is the same idea: promising evidence, more data required.

Where this is taking place

SOHO-01 (NCT05099172) — Phase 1/2, open-label, multi-cohort, still listed recruiting (CT.gov verified 10 Aug 2026). Sponsor: Bayer. Estimated enrolment 400. No Canadian sites on CT.gov. Countries with sites include China, the United States, Japan, Italy, France, South Korea, Spain, Taiwan, Brazil, Hong Kong, the Netherlands, Singapore, Belgium, Israel, Poland, and Portugal. Expansion groups include previously treated HER2-mutant NSCLC naïve to HER2-targeted therapy (Group D), prior HER2 ADC (Group E), and treatment-naïve disease (Group F). Since 9 September 2026, Group F is part of the United States label. It is not part of the Canadian label.

SOHO-02 (NCT06452277 / Study 22615) — Phase 3 confirmatory first-line trial. Recruiting (ClinicalTrials.gov record verified 9 Sep 2026). Sevabertinib 20 mg twice daily vs pembrolizumab plus platinum/pemetrexed. The trial aims to enrol 555 people. This is an estimate, not an actual count. Non-squamous NSCLC with a HER2 TKD activating mutation; no prior systemic therapy for advanced disease. It has 279 locations in 36 countries. Canadian sites on CT.gov: BC Cancer (Vancouver) completed; Brampton Civic Hospital (Brampton, Ontario) recruiting; Princess Margaret Cancer Centre (Toronto) recruiting; Jewish General Hospital (Montreal) recruiting. It is a first-treatment trial, and people in it are assigned a treatment at random. It is not a prescription route for someone already treated. In the United States, people starting first treatment can now be prescribed Hyrnuo. In Canada, the label is still for use after prior systemic therapy. So Canadians starting first treatment need this trial or another option from their specialist.

panSOHO (NCT06760819) — Phase 2 basket in other solid tumours with HER2-activating mutations. NSCLC is an exclusion. Not an enrolment path for this article.

NCT06761976 — Bayer expanded-access program, status available, for previously treated locally advanced or metastatic HER2-mutant NSCLC with no other therapeutic option. CT.gov lists no sites. It does not change the access level shown above. Not a Canadian route for a labelled, marketed DIN.

Commercial supply: United States (first treatment or later, since 9 September 2026). Canada (marketed; after prior systemic therapy). United Kingdom (authorised; after prior treatment). Japan: in-country after MHLW, broader indication on the PMDA table. China: company NMPA. European Union: no EC licence found.

Approval matrix

Access by country

• United States: Thoracic oncologist. FDA-labelled 19 Nov 2025 for adults with locally advanced or metastatic non-squamous NSCLC, HER2 TKD activating mutation on an FDA-authorized test. Since 9 Sep 2026 this includes first treatment, as well as use after prior systemic therapy. 20 mg (two 10 mg tablets) twice daily with food. Swallow whole. USPI does not mandate a REMS or specialty pharmacy; retail vs specialty is unknown from the label. Bayer US: HYRNUO-us.com or 1-888-842-2937 (USPI). No copay dollars here. Prior authorization still applies. Both uses are under accelerated approval.
• Canada (does not change the access level shown above): Authorized with conditions (NOC/c) and marketed (DIN 02563444; first sale 24 Apr 2026). Adult locally advanced or metastatic NSCLC, HER2 TKD activating mutation on a validated test, after prior systemic therapy. Ask the lung-cancer specialist for a prescription. Authorized ≠ funded. CDA-AMC and pCPA listing status unknown / not confirmed on this page. Provincial / territorial / NIHB / RAMQ listing unknown / not confirmed on this page. Because Hyrnuo is authorised and sold in Canada, it is prescribed the usual way, not through Health Canada’s Special Access Program. Bayer Canada Medical Information: 1-800-265-7382 or canada.medinfo@bayer.com (Product Monograph) — that is medical information, not a copay program. First-treatment patients are not on the Canadian label, which remains after prior systemic therapy. For them, SOHO-02 is the trial route (three recruiting Canadian sites above). Do not mail-order a US bottle.
• United Kingdom: MHRA authorised 1 Apr 2026. The GOV.UK body is prior-treatment / HER2 mutations, not IHC “HER2-positive.” NICE GID-TA11814 is awaiting development, not a recommendation. Ask the NSCLC clinic; do not assume NHS routine funding. SMC not found.
• European Union: No EC marketing authorisation found. SOHO-02 is recruiting in multiple EU countries as a first-line trial. Documented expanded access (NCT06761976) exists on paper with no CT.gov sites. Named-patient import is a specialist/legal plan, not a DIY order. Do not treat CHMP as a licence; none was found.
• Japan: In-country commercial after MHLW 24 Aug 2026. PMDA table: HER2 mutation-positive unresectable advanced or recurrent NSCLC, no line restriction in the table. Company says 1L is included. NHI unknown. Not a Canadian or United States travel path. The Canadian label still requires prior therapy.
• China: In-country commercial per Bayer (赫新诺). NMPA page not retrieved. After one prior systemic therapy on the company indication. NRDL not found. Not a Canadian travel path.
• Australia / Switzerland / Israel: Authorisation not found on documents checked. Specialist + local special-access / trial if those programs apply.

If your regulator has not authorised it: do not import on your own. Ask about travelling to a labelled market (US, Canada, UK, Japan) only as a plan with both specialists.

Who is eligible (from the labels — they are not the same)

This is a mutation conversation, not a HER2-protein (IHC) conversation. HER2 amplification or overexpression without a TKD activating mutation is not the US or Canadian indication.

United States (label revised September 2026):

• Adult.
• Locally advanced or metastatic non-squamous NSCLC.
• Tumour has a HER2 (ERBB2) TKD activating mutation, as detected by an FDA-authorized test.
• No prior systemic therapy is required since 9 September 2026. It can be the first treatment or a later one.
• Take 20 mg twice daily with food until progression or unacceptable toxicity.

Canada (Product Monograph / SBD):

• Adult.
• Locally advanced or metastatic NSCLC (the authorised sentence does not say non-squamous).
• Tumours have HER2 (ERBB2) TKD activating mutations.
• Has received a prior systemic therapy.
• Confirm the mutation with a validated test before starting.
• Same dose: 20 mg (two 10 mg tablets) twice daily with food.
• NOC/c: patients should be told the authorisation is with conditions. An improvement in survival has not been established.
• Hypersensitivity to sevabertinib or any tablet ingredient is a contraindication on the Canadian PM (the USPI lists none).
• Pediatrics: not authorised. Geriatrics: HC says numbers were too small to know if older adults respond differently.

Japan (PMDA table, not the US label):

• HER2 (ERBB2) gene mutation-positive unresectable advanced or recurrent NSCLC.
• Table row does not require prior systemic therapy and does not restrict to TKD. Company says all lines including 1L, and not limited by mutation subtype. That sentence does not travel to a Canadian clinic. The United States uses its own label, which includes first treatment since 9 September 2026.

United Kingdom (GOV.UK news pending SmPC):

• Adults with advanced NSCLC with HER2 mutations that has spread or cannot be removed, after prior treatment, with testing before start. Treat the headline “HER2-positive” as sloppy until the SmPC is in hand.

Not labelled in the US or Canada (unless noted):

• First treatment for untreated advanced disease: not on the Canadian label. The United States label has included it since 9 September 2026.
• Squamous NSCLC on the US line (Canada’s sentence does not say non-squamous; SBD noted squamous data were limited).
• HER2 mutations outside the TKD on the US/Canada lines.
• Children.
• Other solid tumours (panSOHO is a trial, not a label).

What the pivotal study showed (label vs journal)

Your doctor will follow the label of the country where it is prescribed.

FDA / USPI (SOHO-01 Groups D, E and F, HER2 TKD, non-squamous; label revised September 2026):

• Group F, n=69, had no earlier treatment for advanced disease. Response rate 75% (95% confidence interval 64–85); complete response 6%; partial response 70%. The label gives no median duration of response. Responses lasted from 1.5 to more than 21.6 months. Of the 52 people who responded, 73% responded for at least 6 months and 38% for at least 12 months.
• Group D, n=70, prior systemic therapy, naïve to HER2-targeted therapy: ORR 71% (95% CI 59–82); complete response 2.9%; partial response 69%; median DOR 9.2 months (95% CI 6.3–15.0); DOR ≥6 months in 54% of responders; DOR ≥12 months in 18%. Median age 59; 67% female; 70% Asian; all adenocarcinoma; 91% stage IV; 20% stable brain metastases; 70% YVMA exon 20 insertion; 94% prior platinum; 71% prior immunotherapy.
• Group E, n=52, prior HER2-targeted ADC: ORR 38% (95% CI 25–53); median DOR 7 months (95% CI 5.6–NE); DOR ≥6 months in 60% of responders.

Health Canada PM / SBD (14 Oct 2024 cut, TKD subgroup):

• Group D TKD n=73: ORR 65.8% (95% CI 53.7–76.5); median DOR 6.8 months (95% CI 5.2–NE); DOR ≥6 months in 27.1% of responders. Disease control rate 82.2%. These numbers are not the FDA table.

NEJM (Le et al., 17 Oct 2025; later data-cut in the paper): Cohort D n=81 ORR 64%; Cohort E n=55 ORR 38%; Cohort F (untreated) n=73 ORR 71%, median DOR 11.0 months. Untreated disease is on the United States label since 9 September 2026 (label Group F, 69 people, shown above). It is not on the Canadian label.

This is tumour shrinkage and response duration on a single-arm trial, not a proven survival win. The confirmatory trial is SOHO-02.

How it is taken (labelled)

20 mg (two 10 mg red-brown tablets marked SE / 10) by mouth twice daily, with food, until the cancer grows or side effects are not manageable. Swallow whole. Do not cut, crush, or chew.

Missed dose: take when remembered before the next scheduled dose; do not double. Vomited dose: skip; take the next one on time.

Dose reductions (US and Canada): first → 10 mg twice daily; second → 10 mg once daily; stop if 10 mg once daily is not tolerated.

Strong CYP3A inhibitors: avoid; if unavoidable, cut the current total daily dose in half (US Table 3 / Canadian Table 3). Avoid strong and moderate CYP3A inducers (US); Canadian PM: strong CYP3A4 inducers not recommended. Avoid grapefruit and St John’s wort.

US: no dose adjustment described for mild hepatic or mild/moderate renal impairment; moderate/severe hepatic and severe renal unknown. Canada: moderate or severe hepatic impairment not recommended.

Companion diagnostic / HER2 TKD testing

Ask for HER2 (ERBB2) mutation testing of the tyrosine kinase domain, usually on a broad NGS panel of the tumour (sometimes plasma). This is not the HER2 IHC/FISH test used in breast cancer.

United States: the label requires an FDA-authorized test. FDA contemporaneously approved the Oncomine Dx Target Test (Life Technologies Corporation / Thermo Fisher) as the companion diagnostic for HER2 TKD activating mutations in non-squamous NSCLC for sevabertinib. See FDA Companion Diagnostics. In SOHO-01, local labs enrolled patients; a retrospective Oncomine subset was almost entirely positive when evaluable.

Canada: confirm the mutation with a validated test before starting (PM). No named companion diagnostic on the monograph.

If prior NGS did not report ERBB2 / HER2 exon 20 insertions or other TKD mutations, ask whether the panel covers them.

Safety (from the United States label; the Canadian monograph differs, as noted)

The United States label has no boxed warning. The percentages below come from the United States label revised September 2026 (pooled group of 287 people), unless noted.

“Warnings and Precautions” on the United States label revised September 2026 (the main safety risks to watch for):

• Diarrhea: can be severe, with dehydration and electrolyte loss. Pooled safety group (n=287; US label, September 2026): diarrhea 89%, Grade 3 16%. Median time to first onset four days. At the first loose stool or extra bowel movements, start an antidiarrheal (e.g. loperamide), increase fluids and electrolytes, and call the clinic. Have anti-diarrhea medicine before the first dose.
• Hepatotoxicity: monitor ALT, AST, and total bilirubin at baseline, every 2 weeks for the first month, then monthly as indicated. Pooled (n=287; US label, September 2026): liver injury (hepatotoxicity) 29% (3.1% Grade 3, 0.3% Grade 4); lab ALT increase 41%, AST 44%.
• ILD / pneumonitis: can be severe. Pooled (n=287; US label, September 2026): four patients (1.4%), including 0.3% Grade 3. New or worsening shortness of breath, cough, or fever → call immediately. Permanently discontinue if ILD/pneumonitis is confirmed (any grade, US and Canada).
• Left ventricular dysfunction (weaker pumping by the heart’s main chamber): The United States label (September 2026) adds this warning. It says Hyrnuo “can cause severe left ventricular dysfunction.” In its pooled safety group of 287 people, one patient (0.3%) had a severe drop in heart pumping. Hyrnuo was stopped for good, and the drop recovered. The label says to check heart pumping before starting and regularly during treatment. Hyrnuo has not been studied in people with significant heart disease or weak heart pumping before treatment. The Canadian product monograph (29 January 2026) does not include this warning.
• Ocular toxicity: 17% pooled (n=287; US label, September 2026), including one Grade 3 case of corneal epithelial microcysts with temporary unilateral blindness. New eye symptoms → ophthalmology.
• Pancreatic enzyme elevation: Pooled (n=287; US label, September 2026): lab amylase increase 39% (3.9% Grade 3, 0.7% Grade 4); lipase 48% (13% Grade 3, 1.1% Grade 4). Monitor amylase and lipase.
• Embryo-fetal toxicity: can cause fetal harm. Effective contraception for females and for males with female partners of reproductive potential during treatment and for 1 week after the last dose. Verify pregnancy before starting. Do not breastfeed during treatment and for 1 week after.

Most common side effects (over 20%; n=287, US label, September 2026): diarrhea, rash, paronychia (nail-fold infection or swelling), nausea, vomiting, mouth sores (stomatitis). Most common severe lab changes (Grade 3–4, in at least 2% of people): low potassium, high lipase, low phosphate, low lymphocytes and low sodium. The same list continues with high amylase, low hemoglobin, high liver enzymes (ALT and AST) and low calcium.

In Groups D, E and F (191 people; US label, September 2026), 33% had a serious side effect. 4.2% stopped Hyrnuo for good because of a side effect.

Canadian product monograph (29 January 2026; pooled group of 268): diarrhea 84.3% (Grade 3 14.2%); lab ALT increase 34.7%, AST 35.5%. In the same group: lung inflammation in 1 patient (0.4%, Grade 3); eye problems 8.6%; amylase increase 31.7%; lipase increase 39.9%.

Canadian PM Group D (n=81): diarrhea 84.0% (Grade 3 23.5%), rash 71.6%, paronychia 30.9%. ILD/pneumonitis 0.4% (one Grade 3) in the pooled 20 mg BID set on the Canadian warnings section.

US contraindications: none. Canada: hypersensitivity to the drug or any ingredient (the tablet contains lactose monohydrate).

Research team (Who)

Names below appear on NCT, label, SBD, or the NEJM paper.

• Bayer — sponsor (SOHO-01, SOHO-02, panSOHO, NCT06761976). US NDA holder: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ. Canada MAH: Bayer Inc., Mississauga. UK MAH: Bayer PLC. Japan MAH: バイエル薬品株式会社.
• Xiuning Le, MD, PhD — first author, NEJM SOHO-01; Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center (as in the NEJM/ESMO byline). Not listed as “overall official” on CT.gov.
• Tae Min Kim; Herbert H. Loong — NEJM co-authors (byline).
• Bayer Clinical Trials Contact — 1-888-842-2937, clinical-trials-contact@bayer.com (SOHO-01 / SOHO-02 / expanded-access CT.gov records).
• Life Technologies Corporation (Thermo Fisher) — Oncomine Dx Target Test, FDA companion diagnostic (FDA bulletin 19 Nov 2025).
• Koichi Goto, PhD — quoted in Bayer’s 24 Aug 2026 Japan announcement as Chief of Thoracic Oncology, National Cancer Center Hospital East. That is a company-quoted clinician, not a CT.gov principal investigator.

No Canadian principal investigator is named on the SOHO-01 record (no Canadian sites). SOHO-02 Canadian sites are listed as facilities, not as named PIs, on CT.gov.

How to talk to a doctor

Bring the NCT numbers and the label of the country you are in.

1. “Has my tumour been tested for a HER2 (ERBB2) tyrosine kinase domain activating mutation, not just HER2 IHC?”
2. “I have had prior systemic therapy. In the US/Canada, is Hyrnuo (sevabertinib) 20 mg twice daily with food the labelled next step, or is a HER2 ADC or another TKI the funded option?”
3. “I have not had drug treatment for advanced disease. In the United States, can I start Hyrnuo by prescription as my first treatment? In Canada, the label is still after prior therapy, so is SOHO-02 (NCT06452277) open for me?” (Canada recruiting sites: Brampton Civic, Princess Margaret, Jewish General. Vancouver BC Cancer is listed completed.)
4. Diarrhea starts fast — “Do I leave with loperamide and a sick-day plan?”
5. Liver, pancreas labs, and new cough/breathlessness (ILD). Eye symptoms → ophthalmology.
6. Pregnancy, contraception for 1 week after the last dose, no breastfeeding for 1 week after.
7. Strong CYP3A drugs, grapefruit, St John’s wort.
8. Canada: “This is NOC/c, marketed, DIN 02563444. So it is prescribed the usual way, not through Health Canada’s Special Access Program. What is actually funded in this province? I do not have a listing answer.”
9. UK: “MHRA yes; NICE GID-TA11814 is awaiting development, not a yes.”
10. EU / Australia / Switzerland: “No licence found. Is the trial or Bayer expanded access (NCT06761976) the route, or a planned visit to a labelled country?”

Canada close-up: authorized with conditions, not funded-by-default

Health Canada has already authorised Hyrnuo, with conditions, and it is on the market. That is not a compassionate-access story. The remaining Canadian questions are who pays (unknown / not confirmed on this page) and line of therapy (the Canadian label is after prior systemic therapy; in Canada, first-line is a trial). Do not call the clinic asking for SAP. Do not assume a provincial cancer-drug program has listed it because a DIN exists.

Bottom line

Sevabertinib is a pill for adults with advanced non-small cell lung cancer and a HER2 tyrosine kinase domain activating mutation. In the United States, accelerated approval covers first treatment and later use since 9 September 2026. In Canada, it is labelled after prior systemic therapy. The UK MHRA has authorised it for adults with advanced NSCLC with HER2 mutations that has progressed after prior treatment (GOV.UK body; SmPC not in hand). Japan’s PMDA table (24 Aug 2026) is HER2 mutation-positive unresectable advanced or recurrent NSCLC without a prior-therapy restriction — that sentence does not travel to a Canadian prescription. China’s NMPA date stays company until nmpa.gov.cn. Europe has no EC licence found. NICE is awaiting development, not a yes. Canada’s NOC/c is authorised-with-conditions, marketed, and not a funding decision. Because it is authorised and sold in Canada, it is prescribed the usual way, not through Health Canada’s Special Access Program. In Canada, SOHO-02 is the first-treatment trial, with three recruiting sites. It is also the trial that must confirm the United States approval. Authorized is not funded.

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Primary sources

1. FDA accelerated-approval bulletin, 19 Nov 2025 — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
2. USPI PDF, NDA 219972 (original label, November 2025; replaced by the September 2026 label, source 25) — https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219972Orig1s000Lbl.pdf
3. DailyMed HYRNUO (setid d7a11334-6e7a-445b-9a16-bdcd9acbe61f) — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7a11334-6e7a-445b-9a16-bdcd9acbe61f
4. FDA Companion Diagnostics — https://www.fda.gov/CompanionDiagnostics
5. Health Canada SBD for Hyrnuo (control 297051; DIN 02563444; NOC/c 2026-01-29; first sale 2026-04-24) — https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1783447155617
6. Health Canada DPD / DHPP product page (Marketed) — https://dhpp.hpfb-dgpsa.ca/dhpp/resource/106622
7. Canadian Product Monograph (HRES) — https://pdf.hres.ca/dpd_pm/00083323.PDF
8. Canadian Product Monograph (Bayer host, Date of Authorization 2026-01-29) — https://www.bayer.com/sites/default/files/2026-02/hyrnuo-pm-en.pdf
9. NOC/c Qualifying Notice, Hyrnuo 297051 — https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions/qualifying-notice-hyrnuo-297051.html
10. Health Canada NOC/c list (Hyrnuo row) — https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html
11. MHRA GOV.UK news, published 2 Apr 2026 (MA 1 Apr 2026, Bayer PLC) — https://www.gov.uk/government/news/sevabertinib-approved-to-treat-adults-with-her2-positive-lung-cancer-that-has-spread-or-cannot-be-removed-by-surgery
12. PMDA 承認品目一覧（新医薬品：2026年8月） — https://www.pmda.go.jp/files/000281577.pdf
13. Bayer Japan/global announcement, 24 Aug 2026 (company 1L claim; not the PMDA table) — https://www.bayer.com/media/en-us/bayers-sevabertinib-approved-in-japan-for-patients-with-her2-mutant-non-small-cell-lung-cancer/
14. Bayer China announcement, 15 Apr 2026 (company NMPA; 赫新诺) — https://www.bayer.com.cn/zh-hans/baierhexinnuoguoneihuopi
15. CPI reprint of NMPA conditional approval, 22 Apr 2026 (not nmpa.gov.cn) — https://www.cpi.ac.cn/zx/xyzl/202604/t20260422_429787.html
16. ClinicalTrials.gov SOHO-01 NCT05099172 — https://clinicaltrials.gov/study/NCT05099172
17. ClinicalTrials.gov SOHO-02 NCT06452277 — https://clinicaltrials.gov/study/NCT06452277
18. ClinicalTrials.gov expanded access NCT06761976 — https://clinicaltrials.gov/study/NCT06761976
19. ClinicalTrials.gov panSOHO NCT06760819 — https://clinicaltrials.gov/study/NCT06760819
20. Le X, Kim TM, Loong HH, et al. Sevabertinib in advanced HER2-mutant non–small-cell lung cancer. N Engl J Med. 2025;393:1819-1832. DOI 10.1056/NEJMoa2511065 (journal; not the label)
21. NICE GID-TA11814 / ID6616 (awaiting development; not a recommendation) — https://www.nice.org.uk/guidance/awaiting-development/gid-ta11814
22. Bayer US first-line application announcement, 18 May 2026 (application; approved 9 Sep 2026, see 24) — https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo
23. Bayer Canada authorisation news, 2 Feb 2026 — https://www.bayer.com/en/ca/health-canada-grants-authorization-for-bayers-hyrnuo
24. FDA approval letter, NDA 219972/S-001, accelerated approval, 9 Sep 2026 (first treatment; confirmatory trial SOHO-02) — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219972Orig1s001ltr.pdf
25. United States label revised September 2026 (S-001) — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219972s001lbl.pdf ; DailyMed version 10, effective 17 Sep 2026 — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7a11334-6e7a-445b-9a16-bdcd9acbe61f
26. Drugs@FDA, NDA 219972 (supplement 1, 9 Sep 2026, new indication) — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972

Who (from sources)