U.S. FDA Accepts New Drug Application Under Priority Review for sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell Lung Cancer

• Regulatory submission is based on positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC).
• Investigational agent sevabertinib (BAY 2927088) is an oral, small molecule, tyrosine kinase inhibitor (TKI) being evaluated as a potential new targeted therapy for patients with NSCLC harboring HER2 activating mutations.
• The U.S. Food and Drug Administration (FDA) grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that supports our ongoing efforts to develop healthcare solutions that help people living with lung cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation.”

The NDA for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial. Results from patients with advanced NSCLC harboring a HER2-activating mutation, who experienced disease progression after ≥1 systemic therapies for advanced disease and were naïve to HER2-targeted therapy.¹

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.²

In 2024, the FDA granted sevabertinib Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. The Breakthrough Therapy designation was supported by preliminary clinical evidence from the SOHO-01 trial. The FDA grants Breakthrough Therapy designation for the evaluation of investigational medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).³

About sevabertinib (BAY 2927088)⁴

Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer-related deaths in the U.S.⁵ Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases.⁴ Activating HER2 mutations are found in 2% to 4% of advanced NSCLC.⁶ 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.⁷ Patients with HER2-mutant NSCLC currently face limited targeted therapies.⁸

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including Tumor Cell Intrinsic Pathways, Targeted Radionuclide Therapies, and selective Next-Generation Immuno-Oncology. With our portfolio we are advancing cancer treatments from early to metastatic stage, with the goal of extending survival while limiting side effects for the cancer patients we serve.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. Le X, et al. Safety and efficacy of BAY 2927088 in patients with HER2-mutant NSCLC: expansion cohort from the phase I/II SOHO-01 study. Presented at the 2024 IASLC World Conference on Lung Cancer; San Diego, CA, September 7-10, 2024. PL04.03.
2. U.S. Food and Drug Administration. “Priority Review.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed April 21, 2025.
3. U.S. Food and Drug Administration. “Breakthrough Therapy.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy. Accessed April 21, 2025.
4. First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/​or Human Epidermal Growth Factor Receptor 2 (HER2). Clinical trial registration No. NCT05099172. https://clinicaltrials.gov/study/NCT05099172. Accessed April 21, 2025.
5. American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 21, 2025.
6. Nützinger, J, et al. (2023). Management of HER2 alterations in non-small cell lung cancer – The past, present, and future. Lung cancer (Amsterdam, Netherlands), 186, 107385. https://doi.org/10.1016/j.lungcan.2023.107385
7. Yale Medicine. “Non-Small Cell Lung Cancer.” https://www.yalemedicine.org/conditions/non-small-cell-lung-cancer. Accessed April 21, 2025.
8. Uy NF,et al. HER2 in Non-Small Cell Lung Cancer: A Review of Emerging Therapies. Cancers (Basel). 2022 Aug 27;14(17):4155. doi: 10.3390/cancers14174155. PMID: 36077691; PMCID: PMC9454740.

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