New Pill for a Gene-Related Advanced Lung Cancer

Who this is for

Next clinical step

Health Canada and the US Food and Drug Administration (FDA) have approved this medicine. In Canada and the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.

Ways to access this treatment

• United States · Prescription

  US prescription (FDA-labelled)

  https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7a11334-6e7a-445b-9a16-bdcd9acbe61f

• Canada · Prescription

  Canada prescription (Health Canada NOC, DIN 02563444)

  https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106622

• United States, Canada · Recruiting clinical trial

  A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

  Tests this treatment. First-line sevabertinib vs standard chemo-immunotherapy (randomised phase 3; FDA's required confirmatory trial, PMR 4933-1). The US label now covers first-line use under accelerated approval (Sep 2026); the Canadian label is still after prior systemic therapy.

  https://clinicaltrials.gov/study/NCT06452277

• United States · Coverage help

  US co-pay help: HYRNUO $0 Co-Pay Program (Bayer)

  https://www.hyrnuo-us.com/copay-program

See 1 trial on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=non-small%20cell%20lung%20cancer&intr=sevabertinib&aggFilters=status:rec

Search Health Canada's Clinical Trials Search Portal: https://clinical-trials-search.canada.ca/en/search?search_api_fulltext=sevabertinib

Possible routes (not confirmed)

• Company expanded-access programme · Applicability unknown

  Bayer expanded access programme NCT06761976 (HER2-mutant NSCLC after prior systemic therapy, ≥18)

  EAP record lists no sites and was last verified 2026-07; it is unclear whether it takes patients where Hyrnuo is sold (US, Canada).

  https://clinicaltrials.gov/study/NCT06761976

• Canada · Coverage help · Applicability unknown

  Canada funding: public drug plans / Bayer Canada support (not confirmed)

  No public-plan review or listing yet (no CDA-AMC or pCPA file found) and no Bayer Canada support programme found; coverage depends on private plans or case-by-case provincial decisions.

  https://www.pcpacanada.ca/negotiations?combine_2=sevabertinib

General resources for further research

• Canadian Cancer Trials Group

  A national network conducting clinical trials for cancer treatment. Patients can search for trials by cancer type and location.

  https://www.ctg.queensu.ca/

• Canadian Clinical Trial Search Portal (Health Canada)

  Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.

  https://clinical-trials-search.canada.ca/en/home

• ClinicalTrials.gov

  US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.

  https://clinicaltrials.gov/