Enhertu for Non-Small Cell Lung Cancer
- The FDA has now approved a targeted therapy called Enhertu for HER2-mutant metastatic or unresectable (non-operable) non-small cell lung cancer (NSCLC).
- The drug was approved for patients who already received one systemic therapy.
- Looking for an error in the HER2 gene can help doctors determine the best course of treatment for NSCLC.
- The new FDA approval makes Enhertu the first drug specifically approved for HER2-mutant NSCLC.
- At the same time, the FDA also approved two diagnostic tests that can be used to detect HER2 mutations in lung cancer patients.
Enhertu is a targeted therapy, which means it specifically identifies and attacks certain types of cancer cells. You may hear doctors refer to it as an antibody-drug conjugate targeted therapy. Last week, the FDA granted an accelerated approval to use the drug for patients with HER2-mutant non-small cell lung cancer (NSCLC) who had already received a prior systemic therapy. An error in the HER2 gene is something that doctors can look for when deciding how to treat NSCLC, as well as several other cancers. About 2% of lung cancer patients have a HER2 mutation, according to the American Lung Association.
Read MoreWhy is Enhertu so promising?
The FDA’s approval of the drug was based on results from the DESTINY-Lung02 trial. The study showed that more than 57% of patients with previously unresectable (that means it can’t be removed with surgery) or metastatic (meaning it has spread to distant parts of the body) HER2-mutant NSCLC responded to the drugs. However, since the FDA’s approval was “accelerated,” Enhertu’s full approval may depend on how it performs for this specific type of lung cancer in future trials.
At the same time, the FDA also approved two diagnostic tests that can be used to detect HER2 mutations in lung cancer patients.
The lung cancer approval comes shortly after Enhertu was approved for HER2-low unresectable or metastatic breast cancer, a groundbreaking approval that came four months ahead of schedule, and is providing a huge amount of hope in the field.
For breast cancer, knowing HER2 status can be incredibly important when determining the right course of treatment as well.
“The HER2 receptor and the discovery of it has really revolutionized and changed the landscape for how we treat breast cancer,” Dr. Elizabeth Comen, a breast oncologist at Memorial Sloan Kettering Cancer Center, told SurvivorNet in a previous conversation.
HER2 status is also important when it comes to breast cancer treatment. Here, Dr. Elizabeth Comen explains how HER2 can help when determining the right form of treatment.
“It can be very responsive to what we called targeted antibody therapies,” she continued. “What does that mean? So … this HER2 receptor sits on the outside of the cell, but there are ways that we can actually block the ability of that HER2 receptor to stimulate the cell from growing.”
Enhertu has also been approved to treat HER2-positive advanced stomach cancer.
Possible side effects
In the FDA’s approval announcement, they also noted some common side effects that have been observed so far when treating HER2-mutant NSCLC. These include:
- Naseau/vomiting
- Decreased white blood cell count
- Decreased hemoglobin
- Fatigue
- Constipation
- Decreased appetite
There were several other potential side effects listed as well. Before beginning any new treatment, it’s important to discuss potential side effects with your doctor or medical team.
Questions to Ask Your Doctor
- What is my HER2 status & am I eligible to be treated with Enhertu?
- What will the treatment plan look like?
- Should I have reservations about Enhertu since it was given an “accelerated” approval?
- What potential side effects should I be aware of?
- How can we weigh the risks vs. benefits of this new drug?
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