75% of patients with a specific HER2-mutant lung cancer (NSCLC) saw their tumors shrink in early trials for a new drug, sevabertinib. FDA's accelerated approval means a vital new treatment option for this aggressive cancer type where options were once very limited.
U.S. FDA grants accelerated approval to Bayer's targeted therapy sevabertinib as a first-line treatm
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib, an oral targeted therapy from Bayer, for adults with locally advanced or metastatic non-squamous non-small
www.fda.gov
September 12, 2026 at 2:05 PM
75% of patients with a specific HER2-mutant lung cancer (NSCLC) saw their tumors shrink in early trials for a new drug, sevabertinib. FDA's accelerated approval means a vital new treatment option for this aggressive cancer type where options were once very limited.
71% response rate in a lung cancer trial (NSCLC with HER2 mutations) getting FDA priority review... What if more cancers could be treated this way?
Frontline Sevabertinib Earns FDA Priority Review in HER2-Mutated NSCLC
The FDA has granted priority review to a supplemental new drug application for sevabertinib, an investigational treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSC
www.cancernetwork.com
May 19, 2026 at 8:04 AM
71% response rate in a lung cancer trial (NSCLC with HER2 mutations) getting FDA priority review... What if more cancers could be treated this way?
Herbert Loong presenting data on Sevabertinib in ERBB2/HER2 mutated NSCLC #ASCO25
Cohort with no prior treatment and another with no prior HER2 targeted therapy.
Cohort with no prior treatment and another with no prior HER2 targeted therapy.
June 1, 2025 at 2:19 PM
Herbert Loong presenting data on Sevabertinib in ERBB2/HER2 mutated NSCLC #ASCO25
Cohort with no prior treatment and another with no prior HER2 targeted therapy.
Cohort with no prior treatment and another with no prior HER2 targeted therapy.
The @fda.gov approved sevabertinib for HER2-mutant non-small-cell lung cancer, supported by a multi-year research collaboration with colleagues at the @broadinstitute.org. Learn more: bit.ly/49Q2vjd
Dana-Farber research supports FDA approval of sevabertinib for HER2-mutant lung cancer | Dana-Farber Cancer Institute
The US Food and Drug Administration has approved sevabertinib, an oral targeted therapy for adult patients with non-small-cell lung cancer (NSCLC) whose tumors harbor certain HER2 (also called ERBB2) mutations and who have previously received chemotherapy or immunotherapy. The approval reflects a multi-year collaboration led by Dana-Farber Cancer Institute investigators, working closely with colleagues at the Broad Institute.
www.dana-farber.org
November 21, 2025 at 2:30 PM
The @fda.gov approved sevabertinib for HER2-mutant non-small-cell lung cancer, supported by a multi-year research collaboration with colleagues at the @broadinstitute.org. Learn more: bit.ly/49Q2vjd
The FDA has expanded treatment options for some people with HER2-mutated non-small cell lung cancer (NSCLC), approving Hyrnuo (sevabertinib) as a first-line treatment.
Learn more about the approval: go2.org/blog/fda-mov...
Learn more about the approval: go2.org/blog/fda-mov...
September 11, 2026 at 6:48 PM
The FDA has expanded treatment options for some people with HER2-mutated non-small cell lung cancer (NSCLC), approving Hyrnuo (sevabertinib) as a first-line treatment.
Learn more about the approval: go2.org/blog/fda-mov...
Learn more about the approval: go2.org/blog/fda-mov...
Sevabertinib demonstrates significant antitumor efficacy in advanced cancer, achieving up to 71% response rates with manageable side effects.
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
October 26, 2025 at 6:37 PM
Sevabertinib demonstrates significant antitumor efficacy in advanced cancer, achieving up to 71% response rates with manageable side effects.
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
#ICYMI - The FDA has granted accelerated approval of sevebertinib as a first treatment option for HER2+ #LungCancer, offering patients a targeted oral therapy earlier than before. buff.ly/iSHA0qn
Sevabertinib for HER2+ lung cancer - Lung Cancer Research Foundation
The good news The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small…
www.lungcancerresearchfoundation.org
September 16, 2026 at 1:00 AM
#ICYMI - The FDA has granted accelerated approval of sevebertinib as a first treatment option for HER2+ #LungCancer, offering patients a targeted oral therapy earlier than before. buff.ly/iSHA0qn
You can read more about sevabertinib in the recent Cancer Discovery @aacrjournals.bsky.social article by Franziska Siegel, Matthew Meyerson, Heidi Greulich, and colleagues: doi.org/10.1158/2159...
November 21, 2025 at 8:09 PM
You can read more about sevabertinib in the recent Cancer Discovery @aacrjournals.bsky.social article by Franziska Siegel, Matthew Meyerson, Heidi Greulich, and colleagues: doi.org/10.1158/2159...
FDA GRANTS TRADITIONAL APPROVAL TO AMGEN’S TARLATAMAB-DLLE FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER; FDA ALSO GRANTS ACCELERATED APPROVAL TO BAYER’S SEVABERTINIB FOR NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
November 19, 2025 at 7:59 PM
FDA GRANTS TRADITIONAL APPROVAL TO AMGEN’S TARLATAMAB-DLLE FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER; FDA ALSO GRANTS ACCELERATED APPROVAL TO BAYER’S SEVABERTINIB FOR NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC
https://cancerletter.com/drugs-and-targets/20260918_10b/
https://cancerletter.com/drugs-and-targets/20260918_10b/
FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC - The Cancer Letter
FDA has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advan
cancerletter.com
September 20, 2026 at 1:07 AM
FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC
https://cancerletter.com/drugs-and-targets/20260918_10b/
https://cancerletter.com/drugs-and-targets/20260918_10b/
In advanced HER2-mutant NSCLC, sevabertinib showed antitumor activity, with responses in 64 to 71% of patients not previously treated with HER-directed antibody–drug conjugates and in 38% of previously treated patients. Full SOHO-01 study: nej.md/476jryK
#ESMO25 | @myesmo.bsky.social
#ESMO25 | @myesmo.bsky.social
October 17, 2025 at 2:07 PM
In advanced HER2-mutant NSCLC, sevabertinib showed antitumor activity, with responses in 64 to 71% of patients not previously treated with HER-directed antibody–drug conjugates and in 38% of previously treated patients. Full SOHO-01 study: nej.md/476jryK
#ESMO25 | @myesmo.bsky.social
#ESMO25 | @myesmo.bsky.social
Yesterday, the FDA granted accelerated approval to sevabertinib for HER2-mutated non-small cell lung cancer. The good news: this expands its previous indication, which our Chief Scientific Officer covered in Science Made Simple in December 2025. buff.ly/pPiHAn9
September 10, 2026 at 12:30 PM
Yesterday, the FDA granted accelerated approval to sevabertinib for HER2-mutated non-small cell lung cancer. The good news: this expands its previous indication, which our Chief Scientific Officer covered in Science Made Simple in December 2025. buff.ly/pPiHAn9
BAYER GETS BREAKTHROUGH THERAPY DESIGNATION FOR SEVABERTINIB
January 6, 2026 at 7:31 AM
BAYER GETS BREAKTHROUGH THERAPY DESIGNATION FOR SEVABERTINIB
Sevabertinib demonstrates significant antitumor activity in advanced cancer, achieving up to 71% response rates, though adverse events remain common.
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
November 15, 2025 at 10:32 AM
Sevabertinib demonstrates significant antitumor activity in advanced cancer, achieving up to 71% response rates, though adverse events remain common.
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
by Le X, Kim TM (...) Tan DS et 26 al. in N Engl J Med #MedSky
👉 get more here
📖 read the article: https://www.nejm.org/doi/10.1056/NEJMoa2511065
FDA Grants Priority Review to Sevabertinib for HER2-Mutant NSCLC @fda.gov #lcsm #oncology
www.onclive.com/view/fda-gra...
www.onclive.com/view/fda-gra...
www.onclive.com
May 28, 2025 at 9:21 PM
FDA Grants Priority Review to Sevabertinib for HER2-Mutant NSCLC @fda.gov #lcsm #oncology
www.onclive.com/view/fda-gra...
www.onclive.com/view/fda-gra...
#ScienceMadeSimple: FDA has granted accelerated approval to sevabertinib for treating HER2+ (ERBB2) #LungCancer. LCRF's Chief Scientific Officer, Dr. Toni Wozniak, explains what this means for patients. LCRF.org/sms25121
Sevabertinib for HER2+ lung cancer - Lung Cancer Research Foundation
The good news The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small…
LCRF.org
December 2, 2025 at 5:30 PM
#ScienceMadeSimple: FDA has granted accelerated approval to sevabertinib for treating HER2+ (ERBB2) #LungCancer. LCRF's Chief Scientific Officer, Dr. Toni Wozniak, explains what this means for patients. LCRF.org/sms25121
#ESMO25 | New insights from the SOHO-01 study presented by Prof. NIcolas Girard @institutcurie.bsky.social:
Molecular factors and ctDNA dynamics may help predict outcomes in patients with HER2-mutant #NSCLC treated with sevabertinib, paving the way for more personalized care.
#medonc #lungcancer
Molecular factors and ctDNA dynamics may help predict outcomes in patients with HER2-mutant #NSCLC treated with sevabertinib, paving the way for more personalized care.
#medonc #lungcancer
October 19, 2025 at 1:13 PM
#ESMO25 | New insights from the SOHO-01 study presented by Prof. NIcolas Girard @institutcurie.bsky.social:
Molecular factors and ctDNA dynamics may help predict outcomes in patients with HER2-mutant #NSCLC treated with sevabertinib, paving the way for more personalized care.
#medonc #lungcancer
Molecular factors and ctDNA dynamics may help predict outcomes in patients with HER2-mutant #NSCLC treated with sevabertinib, paving the way for more personalized care.
#medonc #lungcancer
Orforglipron, a GLP-1 Receptor Agonist for Obesity (ATTAIN-1 phase 3 trial) nej.md/4n1nSl2
Safety and Immunogenicity of Lassa Fever Vaccine nej.md/47pstZ9
Sevabertinib in HER2-Mutant NSCLC (SOHO-01 phase 1–2 study) nej.md/476jryK
Subscribe to NEJM: nej.md/subscribe
Safety and Immunogenicity of Lassa Fever Vaccine nej.md/47pstZ9
Sevabertinib in HER2-Mutant NSCLC (SOHO-01 phase 1–2 study) nej.md/476jryK
Subscribe to NEJM: nej.md/subscribe
November 6, 2025 at 2:03 PM
Orforglipron, a GLP-1 Receptor Agonist for Obesity (ATTAIN-1 phase 3 trial) nej.md/4n1nSl2
Safety and Immunogenicity of Lassa Fever Vaccine nej.md/47pstZ9
Sevabertinib in HER2-Mutant NSCLC (SOHO-01 phase 1–2 study) nej.md/476jryK
Subscribe to NEJM: nej.md/subscribe
Safety and Immunogenicity of Lassa Fever Vaccine nej.md/47pstZ9
Sevabertinib in HER2-Mutant NSCLC (SOHO-01 phase 1–2 study) nej.md/476jryK
Subscribe to NEJM: nej.md/subscribe
🚨FDA Approval Alert!
🔔 FDA grants accelerated approval to Sevabertinib for adults with metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy.
➡️ FDA also clears the Oncomine Dx Target Test as a companion diagnostic to identify eligible patients.
🔔 FDA grants accelerated approval to Sevabertinib for adults with metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy.
➡️ FDA also clears the Oncomine Dx Target Test as a companion diagnostic to identify eligible patients.
November 21, 2025 at 2:30 PM
🚨FDA Approval Alert!
🔔 FDA grants accelerated approval to Sevabertinib for adults with metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy.
➡️ FDA also clears the Oncomine Dx Target Test as a companion diagnostic to identify eligible patients.
🔔 FDA grants accelerated approval to Sevabertinib for adults with metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy.
➡️ FDA also clears the Oncomine Dx Target Test as a companion diagnostic to identify eligible patients.
U.S. regulators grant accelerated approval to Bayer’s sevabertinib as a first-line targeted therapy for HER2-mutated NSCLC.
September 10, 2026 at 2:22 AM
U.S. regulators grant accelerated approval to Bayer’s sevabertinib as a first-line targeted therapy for HER2-mutated NSCLC.
Sevabertinib Induces Durable Response in Advanced HER2-Mutant NSCLC #lungcancer #NSCLC #ASCO25 @herbloongmd.bsky.social @ascocancer.bsky.social
www.onclive.com/view/sevaber...
www.onclive.com/view/sevaber...
Sevabertinib Induces Durable Response in Advanced HER2-Mutant NSCLC
Treatment with the oral TKI showed promising responses among 2 subgroups of patients with advanced, HER2-mutant non–small cell lung cancer.
www.onclive.com
June 1, 2025 at 6:47 PM
Sevabertinib Induces Durable Response in Advanced HER2-Mutant NSCLC #lungcancer #NSCLC #ASCO25 @herbloongmd.bsky.social @ascocancer.bsky.social
www.onclive.com/view/sevaber...
www.onclive.com/view/sevaber...
🚨🫁 Sevabertinib has been approved in Japan for the treatment of patients with HER2-mutant non–small cell lung cancer (NSCLC). 🧬📊
Read more ➡️ www.onclive.com/view/sevaber...
#LungCancer #NSCLC #HER2 #HER2Mutation #TargetedTherapy #PrecisionOncology #ThoracicOncology #Oncology
Read more ➡️ www.onclive.com/view/sevaber...
#LungCancer #NSCLC #HER2 #HER2Mutation #TargetedTherapy #PrecisionOncology #ThoracicOncology #Oncology
Sevabertinib Approved in Japan for HER2-Mutant Non–Small Cell Lung Cancer | OncLive
The MHLW approval covers all lines of therapy, including first-line use, in unresectable advanced or recurrent HER2-mutant NSCLC.
www.onclive.com
August 24, 2026 at 6:08 PM
🚨🫁 Sevabertinib has been approved in Japan for the treatment of patients with HER2-mutant non–small cell lung cancer (NSCLC). 🧬📊
Read more ➡️ www.onclive.com/view/sevaber...
#LungCancer #NSCLC #HER2 #HER2Mutation #TargetedTherapy #PrecisionOncology #ThoracicOncology #Oncology
Read more ➡️ www.onclive.com/view/sevaber...
#LungCancer #NSCLC #HER2 #HER2Mutation #TargetedTherapy #PrecisionOncology #ThoracicOncology #Oncology
The authors included RRIDs in their paper! We value the author's support of reproducibility. #reproducibility #ReproducibleResearch #reproducibility
Sevabertinib, a Reversible HER2 Inhibitor with Activity in Lung Cancer
doi.org
January 28, 2026 at 11:02 PM
The authors included RRIDs in their paper! We value the author's support of reproducibility. #reproducibility #ReproducibleResearch #reproducibility
🧬🚀 Emerging agents such as zongertinib and sevabertinib are reshaping care for patients with HER2-mutated NSCLC, delivering impressive response rates and offering new strategies to overcome resistance. 📊⚡
Read more ➡️ www.onclive.com/view/zongert...
#lcsm #Oncology
Read more ➡️ www.onclive.com/view/zongert...
#lcsm #Oncology
Zongertinib, Sevabertinib Reshape Treatment Landscape for Patients With HER2-Mutated NSCLC | OncLive
Experts in lung cancer gathered at an OncLive® Scientific Interchange and Workshop during the 2026 ASCO Annual Meeting to discuss HER2-mutated NSCLC.
www.onclive.com
June 17, 2026 at 3:13 PM
🧬🚀 Emerging agents such as zongertinib and sevabertinib are reshaping care for patients with HER2-mutated NSCLC, delivering impressive response rates and offering new strategies to overcome resistance. 📊⚡
Read more ➡️ www.onclive.com/view/zongert...
#lcsm #Oncology
Read more ➡️ www.onclive.com/view/zongert...
#lcsm #Oncology
US FDA GRANTS PRIORITY REVIEW TO SUPPLEMENTAL NEW DRUG APPLICATION FOR HYRNUO® (SEVABERTINIB) UNDER INVESTIGATION AS A FIRST-LINE TREATMENT OF HER2-MUTATED NON-SMALL CELL LUNG CANCER
May 18, 2026 at 12:45 PM
US FDA GRANTS PRIORITY REVIEW TO SUPPLEMENTAL NEW DRUG APPLICATION FOR HYRNUO® (SEVABERTINIB) UNDER INVESTIGATION AS A FIRST-LINE TREATMENT OF HER2-MUTATED NON-SMALL CELL LUNG CANCER