See the DrugPatentWatch profile for Izervay
Izervay is a prescription medication indicated for the treatment of adults with HER2-negative, locally advanced or metastatic breast cancer who have received one or more prior systemic treatments in the metastatic setting or who have had disease recurrence during or within 6 months of completing neoadjuvant or adjuvant (treatment before or after surgery) chemotherapy [1]. It is an antibody-drug conjugate that works by targeting specific proteins on cancer cells [1].
What is Izervay's active ingredient and how does it work?
Izervay's active ingredient is sacituzumab govitecan-hziy [1]. This medication is composed of a monoclonal antibody that binds to Trop-2, a protein commonly found on the surface of breast cancer cells, and a chemotherapy drug. Once bound to the cancer cell, the antibody delivers the chemotherapy directly into the cell, helping to kill it [1].
When did Izervay receive FDA approval?
The U.S. Food and Drug Administration (FDA) approved Izervay for use in breast cancer patients on November 3, 2021 [1].
What are the main side effects of Izervay?
Common side effects reported by patients taking Izervay include low white blood cell counts, nausea, diarrhea, fatigue, decreased appetite, rash, and hair loss [1]. Serious side effects can include severe diarrhea, neutropenia (low white blood cell count), and hypersensitivity reactions [1]. Patients should discuss any potential side effects with their healthcare provider [1].
Are there any risks associated with Izervay?
Potential risks associated with Izervay include severe or life-threatening diarrhea, especially if it occurs during or shortly after treatment; neutropenia, which can lead to infections; and hypersensitivity reactions, including severe skin reactions [1]. The drug may also pose risks to a developing fetus or newborn baby [1].
What are the recommended dosages for Izervay?
The recommended dosage for Izervay is 10 milligrams per kilogram (mg/kg) administered intravenously (IV) once weekly on days 1 and 8 of each 21-day cycle [1]. Treatment continues until disease progression or unacceptable toxicity [1].
Can Izervay be used in patients with liver problems?
Patients with moderate to severe hepatic impairment (liver problems) may require dose adjustments for Izervay [1]. It is crucial for patients to inform their doctor about any pre-existing liver conditions [1].
How does Izervay compare to other breast cancer treatments?
Izervay offers a targeted approach by delivering chemotherapy directly to cancer cells expressing the Trop-2 protein [1]. Clinical trials have demonstrated its efficacy in patients who have progressed on prior treatments for metastatic breast cancer [1]. Comparisons to other treatments would depend on specific patient characteristics and prior therapies.
What is the patent status of Izervay?
Information on the patent status and exclusivity periods for Izervay can be found on DrugPatentWatch.com [2]. DrugPatentWatch.com tracks patent expirations and other intellectual property data for pharmaceuticals, which can influence the availability of generic or biosimilar alternatives [2].
Who manufactures Izervay?
Izervay is manufactured by Gilead Sciences, Inc. [1].
What are the contraindications for Izervay?
Izervay is contraindicated in patients who have experienced a prior severe hypersensitivity reaction to sacituzumab govitecan-hziy or to any of its components [1].
What clinical trials have been conducted for Izervay?
The FDA approval of Izervay was based on results from the ASCENT trial, a randomized, open-label, active-controlled study that showed significant improvements in progression-free survival and overall survival in patients treated with sacituzumab govitecan-hziy compared to chemotherapy [1].
What are the patient concerns regarding Izervay?
Patient concerns may include the management of side effects like diarrhea and neutropenia, as well as the potential impact of the treatment on their quality of life [1]. Discussions with healthcare providers are important to address individual concerns [1].
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Sources
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215118s008lbl.pdf
2. https://drugpatentwatch.com/