Onco-Summaries: Daily Oncology Updates at a Glance
09/09/2026
US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC (Ref)
The US FDA has granted accelerated approval to Bayer’s sevabertinib (reversible HER2 tyrosine kinase inhibitor) as a first-line treatment for adults with locally advanced or metastatic HER2-mutant non-squamous NSCLC
This decision follows Priority Review and Breakthrough Therapy Designations, underscoring the unmet need for targeted options in this patient population
Approval is based on the data from Phase I/II SOHO-01 trial, which demonstrated a 75% objective response rate, with 73% of responders maintaining benefit for ≥6 months
Continued approval is contingent on results from the ongoing Phase III SOHO-02 trial comparing sevabertinib to standard of care
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