FDA expands Hyrnuo (sevabertinib) use in HER2-mutated lung cancer
核心洞察
The FDA expanded the indication for Bayer (搜索)'s sevabertinib (搜索), marketed as Hyrnuo (搜索), to include first-line treatment of HER2 (搜索)-mutated non-small cell lung cancer (搜索).
In the SOHO-01 trial, Hyrnuo (搜索) produced a 75% objective response rate among 69 previously untreated patients with locally advanced or metastatic HER2 (搜索)-mutated NSCLC.
Responses lasted at least 6 months in 73% of responders and at least 12 months in 38%, with 6% complete and 70% partial responses.
The FDA has expanded the indication for Bayer (搜索)'s sevabertinib (搜索), marketed as Hyrnuo (搜索), to include a rare molecular subtype of non-small cell lung cancer (搜索) (NSCLC). The drug previously received accelerated approval in November 2025 for adults with locally advanced or metastatic non-squamous NSCLC whose tumors harbor HER2 (搜索) (ERBB2 (搜索)) TKD activating mutations and who had received prior systemic therapy.
The expansion follows results from the SOHO-01 trial. Among 69 patients with locally advanced or metastatic HER2 (搜索)-mutated NSCLC who had not previously received systemic therapy, Hyrnuo (搜索) produced an objective response rate of 75%. Responses lasted at least 6 months in 73% of responding patients, and 38% maintained a response for at least 12 months. Bayer (搜索) reported that 6% of patients achieved a complete response and 70% achieved a partial response.
HER2 (搜索) mutations are found in an estimated 2% to 4% of people with NSCLC. The first-line move puts Bayer (搜索) in competition with Boehringer Ingelheim's Hernexeos (搜索) (zongertinib), which received FDA approval for previously treated patients in August 2025 and an expanded first-line approval in February 2026. The Hyrnuo (搜索) approval remains accelerated, requiring confirmatory evidence of clinical benefit, and the ongoing phase 3 SOHO-02 trial is evaluating the drug versus standard treatment in previously untreated patients with advanced HER2-mutated NSCLC. Hyrnuo was also approved in China earlier this year as a second-line treatment for unresectable, locally advanced or metastatic HER2-mutant NSCLC.
Source: Labroots