Topic: The drug Enhertu is FDA-approved for any advanced or metastatic HER2-positive tumors
Summary
The FDA granted accelerated approval of Enhertu for people with any HER2-positive tumor that is metastatic or cannot be surgically removed. Eligible patients must have had previous treatment such as chemotherapy or hormone therapy. (Posted 7/19/24)
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RELEVANCE
Most relevant for: People with advanced HER2-positive cancer.
It may also be relevant for:
- people with breast cancer
- men with breast cancer
- people with metastatic or advanced cancer
- people with pancreatic cancer
- people with prostate cancer
- people with Her2-positive cancer
- people with colorectal cancer
- people with endometrial cancer
- people with ovarian cancer
Relevance: Medium-High
Strength of Science: High
Research Timeline: Post Approval
What is this update about?
Enhertu (fam-trastuzumab deruxtecan-nxki), is a new type of known as an antibody-drug conjugate. Enhertu combines an antibody that targets a tumor marker called with a chemotherapy drug that stops cancer cell division.
Why is this update important?
Enhertu was previously approved only for breast cancer. Although many other types of cancer may be , only a small number of anti-HER2 treatments are available for treating them. Anyone with an advanced tumor (from any cancer) who has received prior treatment may now be eligible for Enhertu.
What led to this update?
The accelerated approval of Enhertu was based on three clinical trials. Participants in these trials included adults with endometrial, cervical, ovarian, bladder, biliary tract, pancreatic, non-small cell lung, colorectal and other cancers. In many cases, Enhertu stopped tumor growth for months to years.
Severe side effect
Enhertu comes with a Boxed Warning by the Food and Drug Administration () to alert users about major risks associated with the drug.
The Enhertu Boxed Warning alerts healthcare providers and patients to the risk of a group of lung diseases collectively known as interstitial lung disease (ILD). ILD causes scarring of the lungs, which creates stiffness that makes it difficult to breathe and get oxygen into the blood. Lung damage from ILD cannot be treated and worsens over time.
In the trial that led to this approval, 16 percent of participants developed ILD. Of these, only 0.6 percent developed ILD that was grade 3 (medically significant but not immediately life threatening) or grade 4 (life threatening).
Common side effects
Side effects of Enhertu include:
- loss of appetite
- nausea
- vomiting
- hair loss
- diarrhea
- constipation
- upper respiratory tract infections
Side effects that are detected by blood work include:
- increases and/or decreases in minerals such as potassium
- decreases in both red and white blood cell counts
What is accelerated approval?
Granting accelerated approval of drugs for serious conditions allows the to approve important new drugs without waiting for more evidence of a long-term clinical benefit, such as improved survival or reduced disease progression. For a drug to qualify, researchers must show a benefit for patients. For cancer patients, this could be a measure of tumor shrinkage. Accelerated approval gives patients earlier access to potentially life-saving treatments while ensuring that ongoing research confirms the anticipated benefit of the drug.
Accelerated approvals are often used when a new drug can help with unmet medical needs. Following accelerated approval, the drug manufacturer is required to continue research. These studies, known as post-marketing or confirmatory trials, help validate the original observation. If continued research shows that the drug is safe and effective, full approval may be granted. However, failure to show clinical benefit could lead to withdrawal of the approval.
What does this mean for me?
If you have HER2-positive cancer that cannot be removed by surgery and has not responded to previous treatments, you may want to ask your doctor if Enhertu is a treatment option for you.
ILD is a serious condition. If you are considering taking Enhertu, all side effects and risk factors for ILD should be discussed with a healthcare provider.
Reference:
grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or HER2-positive breast cancer. News Release. . April 5, 2024.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
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posted 7/19/24
