New Hope for Lung Cancer Patients: Bayer’s Drug Wins FDA Approval
The FDA recently approved a lung cancer treatment, Seebertinib, under the Hyrnuo brand. The drug inhibits the tyrosine kinase function and is especially effective for those adults who are suffering from HER2-mutant nonsquamous non-small cell lung cancer. The drug is also beneficial for those who have already received prior systemic therapy.
According to the FDA, “The efficacy of sevabertinib was evaluated in 122 patients with locally advanced or metastatic, non‑squamous NSCLC with HER2 TKD activating mutations. The overall response rate was 71% in patients who had received prior non‑HER2 targeted therapies and 38% in patients who had received prior HER2‑targeted systemic therapy. The median duration of response was 9.2 months.”
Until now, NSCLC has been prevailing around 80-85% of all lung cancers globally. The HER2 mutation is rare, occurring in only 2-4% of NSCLC cases. However, it’s more aggressive and leaves only a few treatment options. To ensure the correct treatment, the patient should first be diagnosed with lung conditions.
Identification can be achieved through an FDA-approved companion diagnostic test, Oncomine Dx Target Test. This approval is crucial for addressing the unmet need in HER2-mutated NSCLC. The drug is a good addition in oncology, leading the way towards locally fast prevailing lung cancer, which previously had limited cure options.
| Region | Estimated NSCLC Cases (Annual) | HER2 Mutation Share | Notes on Access to Targeted Therapies |
| North America | ~230,000 | 2–4% | Strong access to biomarker testing |
| Europe | ~300,000 | 2–3% | Growing adoption of HER2 diagnostics |
| Asia-Pacific | ~1,000,000+ | 3–4% | Uneven access; high unmet need |
| Middle East/GCC | Rising incidence | 2–3% | Limited HER2‑specific options |
Clinical Evidence and Patient Impact
According to Targeted Oncology, “Sevabertinib received accelerated FDA approval for HER2 TKD‑mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO‑01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as the most common adverse event, not leading to discontinuation.”
SOHO-01 trial phase 02 provided clinical evidence that supports the drug’s approval. The drug achieved an overall response rate of seventy-one percent among those who had already received non-HER2 therapies. Similarly, it shows a 38% response rate among patients receiving HER2-targeted systemic treatment.
The drug demonstrated meaningful durability, with responses lasting a median of 9.2 months. Similarly, its progression-free survival averaged 7.8 months. Hyrnuo directly hits the tumor growth, blocking HER2-driven signaling by inhibiting the oral kinase. According to safety research, the drug is well-tolerated overall.
The Fierce Pharma reported Bayer’s statement that “With Hyrnuo, patients with HER2‑mutated non‑small cell lung cancer now have a targeted therapy option that addresses a critical unmet need. This approval represents an important step forward in advancing precision medicine for lung cancer.”
The patient can feel the slight side effects, just like other drugs. They may either feel a temporary headache or a little nausea. The drug has a low discontinuation rate, which shows that there could be manageable toxicity. Hyrnuo will extend lung cancer survival and improve quality of life.
