The FDA has granted accelerated approval to Hernexeos as a first-choice targeted oral anticancer treatment for adults whose tumors have specific genetic changes known as tyrosine kinase domain (TKD) activating mutations in the human epidermal growth factor receptor 2 (HER2 [ERBB2]) gene, as confirmed by an FDA-authorized test.
Lung cancer is the leading cause of cancer-related deaths across the world, with the yearly number of new cases expected to climb past 3 million by 2040.
NSCLC is the most common form of lung cancer.
Because it is often found late, survival rates are low, with fewer than 1 in 10 people surviving five years after diagnosis; it also often impacts patients’ psychological and physical well-being.
Although rare, about 4% of patients with NSCLC have mutations in their HER2 (ERBB2) gene, which stimulates unrestricted growth of cancer cells, preventing their natural death and helping them spread to other parts of the body.
Why Was It Approved?
The FDA used the accelerated pathway for this approval because a clinical study showed that as a once-daily pill, Hernexeos was safe and effective in producing meaningful tumor shrinkage in previously untreated adults with inoperable or metastatic HER2‑mutant, non-squamous NSCLC. But continued approval of this medicine may depend on confirming that these benefits translate into clear clinical outcomes in a larger ongoing trial.
What Do I Need to Know?
You need an FDA‑authorized test to confirm TKD-activating mutations in your cancer’s HER2 (ERBB2) gene before you start Hernexeos. Take the medicine by mouth once daily, with or without food. Swallow the tablets whole with water. Do not split, crush, or chew them. If you miss a dose, take it within 12 hours. But if more time has passed, skip it and take your next dose at the usual time. The dose depends on your body weight. Treatment continues as long as it’s working and the side effects are manageable. Your health care provider will check your heart function before starting your treatment and will also monitor it during treatment. They will also do blood tests to assess your liver function – every two weeks for the first 12 weeks, and then monthly, depending on your health status. Tell your health care provider about all of your medical conditions and all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Certain medicines that affect how your liver processes medicines (CYP3A inducers) can lower the amount of Hernexeos in your body and make it less effective. Other medicines (certain BCRP transporter medicines) are very sensitive to small changes in medicine levels, so taking them with Hernexeos may require close monitoring to help keep you safe.
