MHRA approves sevabertinib (Hyrnuo) for previously treated HER2-mutant advanced NSCLC, supported by strong response rates and durable clinical benefit.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved sevabertinib (Hyrnuo) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutations, whose disease has progressed following prior therapy. The approval applies to patients with metastatic disease or tumors that cannot be surgically removed.
Sevabertinib is indicated specifically for patients with confirmed HER2 gene alterations. Testing for these mutations is required before treatment initiation to ensure appropriate patient selection.
The drug is a protein kinase inhibitor that targets abnormal HER2 signaling, a known driver of tumor growth in this subset of lung cancer. By blocking HER2 activity, sevabertinib helps slow disease progression and may induce tumor shrinkage. Clinical trial data showed a 71% response rate in previously treated patients, with many responses lasting six months or longer.
In a statement, MHRA leadership noted that the approval introduces a new treatment option for patients with HER2-positive advanced lung cancer, while emphasizing that ongoing safety monitoring will continue as real-world use expands.
The safety profile of sevabertinib is consistent with other agents in its class. The most commonly reported adverse events include diarrhea, skin reactions, stomatitis, and paronychia. Patients are advised to report side effects to healthcare professionals or through the MHRA Yellow Card scheme.
The approval was granted to Bayer PLC on April 1, 2026, and was conducted under Project Orbis, a collaborative framework led by the U.S. Food and Drug Administration. Project Orbis enables concurrent review of oncology therapies across multiple international regulatory agencies to accelerate patient access to promising treatments.
This decision marks another addition to targeted therapy options for HER2-mutated NSCLC, a population with historically limited treatment choices following disease progression.
Reference
Sevabertinib approved to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery, 02 April 2026, Sevabertinib approved to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery – GOV.UK
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.