A New Hope for Lung Cancer Patients: FDA-Approved Sevabertinib Sets a Breakthrough in Targeted Therapy for Lung Cancer
Lung cancer treatment has now taken another step forward meaningfully giving a new hope to the cancer victims. On November 19, 2025, the U.S Food and Drug Administration (FDA) granted an approval to the drug called sevabertinib (Hyrnuo), which is a targeted therapy designed specifically for the adults who are suffering with locally advanced or metastatic nonsquamous non-small cell lung cancer(NSCLAC) which carries HER2 tyrosine kinase domain(TKD) that activates the mutations. These are the aggressive, hard to treat mutations, which is why there are only few limited treatment options present until now.
Approval of this drug will bring new hope to those patients who have already received at least one prior systemic therapy, which makes sevabertinib an important option in the later-line setting.
Why This Approval Matters
HER2 Mutations occur in a small segment of the patients with nonsquamous NSCLS, and traditional treatments including chemotherapy and immunotherapy, often have limited benefits. Targeted therapies for mutations like this are always emerging slowly, therefore the approval of sevabertinib will add another crucial tool for oncologist and it also represents a major advancement for several reasons:
- It directly targets HER2 TKD activating mutations, which are biologically different from HER2 overexpression.
- It demonstrates high response rates in patients who have already undergone therapy before.
- It also offers an option for those patients who didn’t receive HER2 specific TKIs or who have progressed after HER2 targeted antibody-drug conjugates(ADCs).
Approval of The Companion Diagnosis:
Along with the therapy, The FDA also approved the Oncomine Dx Target Test as a companion diagnostic. This is a test that identifies HER2 TKD activating mutations, that makes sure that only eligible patients will receive sevabertinib. Since targeted therapies highly depend on the accurate mutation detection, approval of this diagnosis will play a crucial part on the treatment strategy.
Key Results From The SOHO -01 Trail in Targeted Therapy For Lung Cancer:
SOHO -01 Trail (NCT05099172), an open labelled, multicenter study that involved many patients with unresectable nonsquamous NSCLC has played a key role in providing the supporting data for the FDA decision to approve the drug.
Patients previously Treated, but TKI naive
- Objective response rate (ORR) is 71%
- Median duration of response(DOR) is 9.2 months
- 54% of the responders maintained responses for less than 6 months.
These results have been striking for previously treated populations.
Patients previously treated with HER2 targeted ADCs
- ORR Is 38%
- Median DOR is 7 months
- 60% of the responders maintained response for less than 6 months.
Despite being heavily treated before, this group still has achieved a meaningful clinical benefit.
Safety and Dosing
Like any other Kinase Inhibitors, sevabertinib also carries several warnings, that includes the following risks:
- Diarrhea
- Hepatotoxicity
- Interstitial Lung Disease, Pneumonitis
- Ocular toxicity
- Pancreatic enzyme elevation
- Embryo-fetal toxicity
The recommended dose of this drug is 20mg orally twice a day along with food, will be continued until the disease progression or unacceptable toxicity.
Global Collaboration and The Next Steps In Targeted Therapy For Lung Cancer:
This approval is a part of the project Orbis, which is a collaborative review program that involves regulatory agencies in Canada, Israel, and the United Kingdom. Sevabertinib has also received a priority review, breakthrough therapy and orphan drug designations that address the importance of the medical need for unmet therapies.
For the individuals who are living with HER2 mutant non-squamous NSCLS, the treatments that are available are limited and this approval will offer a precise, mutation-targeted therapy with strong response rates in previously treated patients, with a meaningful advancement towards more personalized lung cancer therapies.
As ongoing studies will continue, more data will help to determine whether the drug moves towards full approval in the future.
