A new treatment option is now available for some people with advanced non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to HYRNUO® (sevabertinib) as a first line treatment for adults with locally advanced or metastatic non squamous non small cell lung cancer (NSCLC) whose tumors have certain activating HER2 mutations.
This is important because HER2 mutations are one of the molecular changes that can drive lung cancer growth. They are found in approximately 2% to 4% of people with advanced NSCLC and can occur in people who have never smoked.
Why biomarker testing matters
This approval is another example of how understanding the specific biology of a person’s lung cancer can help guide treatment.
In the Phase I/II SOHO-01 trial, 75% of previously untreated patients in the relevant study group experienced a tumor response to HYRNUO. Of those who responded, 73% maintained their response for at least six months and 38% maintained their response for at least 12 months.
The approval also highlights why comprehensive biomarker testing at diagnosis is so important. Identifying actionable mutations can help patients and their care teams determine which treatments may be appropriate as early as possible.
What does this mean for patients?
For people whose lung cancer has a HER2 TKD activating mutation, this approval provides another targeted treatment option to discuss with their oncology team.
It is also a reminder that lung cancer treatment continues to evolve. As researchers learn more about the molecular characteristics of lung cancer, new targeted therapies can offer options that were not available just a few years ago.
HYRNUO’s approval is an accelerated approval, meaning continued approval may depend on confirmation of clinical benefit in an ongoing Phase III trial.
As with any cancer treatment, HYRNUO can cause side effects, and patients should talk with their healthcare team about whether it is appropriate for them and what to expect during treatment. The full prescribing information includes important safety information.
Want to learn more about the FDA approval, clinical trial results, and important safety information?
Read the full press release from Bayer for complete details.
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