IPM Take
The medicine is only half the story. FDA explicitly requires an authorised test for HER2 activating mutations. That moves molecular profiling further upstream and makes turnaround time a treatment issue. Precision medicine fails if the right drug exists but the mutation is discovered after the first-line decision has already been made.
Executive Summary
The FDA granted accelerated approval to sevabertinib (Hyrnuo) for adults with locally advanced or metastatic non-squamous NSCLC whose tumours harbour HER2/ERBB2 tyrosine kinase domain activating mutations, removing the previous requirement for prior systemic therapy. In 69 treatment-naive patients in SOHO-01, confirmed objective response rate was 75%. Among responders, 73% maintained response for at least six months and 38% for at least 12 months. FDA authorised an expanded companion-diagnostic indication for the Oncomine Dx Express Test the same day.
Why it matters
- Patients / advocates: The targeted option can now be considered before systemic therapy has already failed.
- Diagnostics / pathology: HER2 mutation testing becomes part of the initial advanced-lung-cancer work-up.
- Clinicians: Treatment sequencing changes when a target is actionable from first line.
- Regulators / payers: Accelerated approval means confirmatory evidence still matters.
Precision oncology is often delayed by one appointment.
A biopsy is taken. The diagnosis comes back. Treatment needs to start. Molecular testing is ordered later. By the time the mutation is found, the first-line decision has already happened.
Sevabertinib’s new FDA indication makes that workflow harder to defend.
The approval now covers treatment-naive locally advanced or metastatic non-squamous NSCLC with activating HER2 mutations. In SOHO-01, three quarters of patients responded. The result is early but substantial enough to move the target from “interesting later” to “actionable now.”
That means HER2 testing has to move with it.
FDA simultaneously expanded the Oncomine Dx Express Test as a companion diagnostic. That regulatory pairing matters. The treatment and the test are now formally linked.
Health systems should read the message clearly: molecular diagnostics cannot remain a downstream luxury in advanced lung cancer.
Accelerated approval also demands some restraint. SOHO-01 is single-arm. Response rate and duration support access, but confirmatory randomized evidence is still required. FDA’s ongoing accelerated-approval record lists the SOHO-02 trial as the study expected to verify clinical benefit.
That is how the system should work: move early when the signal is strong, then demand that the signal survives harder testing.
Patients need both speed and evidence. They should not have to choose between them.
