What is the name of the drug and what does it do?
Hympavzi (pronounced him-PAV-zee), generic name marstacimab-hncq, is a medicine used to reduce or prevent bleeding episodes in people with hemophilia A or B. This treatment is specifically for individuals aged 12 years and older who do not have inhibitors (antibodies) against factor VIII or factor IX. Was Approved on October 11, 2024.
How does it work?
Hympavzi works by blocking a protein called tissue factor pathway inhibitor (TFPI). TFPI slows down the blood clotting process. By stopping this protein, Hympavzi enhances the body’s ability to form clots and stop bleeding.
What did the research discover?
In a clinical trial involving 116 patients with hemophilia A or B, Hympavzi showed significant improvements in reducing annualized bleeding rates (ABR). Patients who previously used on-demand treatments saw their ABR decrease from an average of 38 to just 3.18 when switched to Hympavzi. Even those using routine prophylaxis experienced better outcomes with Hympavzi, showing fewer bleeding events overall.
What are some of the side effects?
The most common side effects of Hympavzi include:
- Injection site reactions (redness, swelling, or itching)
- Headache
- Itching (pruritus)
Rare but serious side effects include blood clots (thromboembolic events) and severe allergic reactions. Patients should contact their healthcare provider if they experience symptoms such as chest pain, trouble breathing, swelling in the legs, or severe itching and swelling of the face.
What are the dosage recommendations and how is it prescribed?
Hympavzi is given as an injection under the skin (subcutaneous) once a week.
- Loading dose: 300 mg (two injections of 150 mg) given on the same day.
- Maintenance dose: One week after the loading dose, patients receive a 150 mg injection every week, on the same day each week.
If breakthrough bleeding occurs, patients may use factor VIII or IX products, as recommended by their doctor. For major surgeries, Hympavzi should be temporarily stopped, and alternative clotting factor therapy should be used.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for BLA 761369]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761369s000lbl.pdf. Accessed 2024 Nov 21.
Vyloy: A New Stomach Cancer Treatment Approved on October 18, 2024
What is the name of the drug and what does it do?
Vyloy (pronounced vye-LOY), generic name zolbetuximab-clzb, is a prescription medicine used with specific chemotherapy drugs (fluoropyrimidine and platinum-based) to treat stomach cancer (gastric cancer) and cancer where the esophagus meets the stomach (gastroesophageal junction cancer). It is approved as a first-line treatment for adults whose cancer cannot be removed by surgery or has spread, is HER2-negative, and tests positive for a protein called claudin 18.2.
How does it work?
Vyloy is a type of drug known as a cytolytic antibody. It specifically targets cancer cells with the claudin 18.2 protein on their surface. Once bound, Vyloy triggers the immune system to destroy these cancer cells, either directly or by activating immune responses.
What did the research discover?
Clinical trials showed that Vyloy, when combined with chemotherapy, improved survival and slowed disease progression in patients with advanced stomach or gastroesophageal cancer.
- In one study, patients treated with Vyloy and chemotherapy had a median progression-free survival of 10.6 months, compared to 8.7 months for those on chemotherapy alone.
- Median overall survival was 18.2 months for the Vyloy group, compared to 15.5 months for the placebo group.
- Vyloy increased the number of patients with tumor shrinkage compared to those who received chemotherapy alone.
What are some of the side effects?
The most common side effects of Vyloy include:
- Nausea and vomiting
- Fatigue
- Decreased appetite
- Diarrhea or constipation
- Abdominal pain
- Weight loss
- Fever
- Tingling or numbness in the arms or legs
Severe allergic reactions, such as anaphylaxis or infusion-related reactions, may occur. Patients are closely monitored during and after treatment for these reactions.
What are the dosage recommendations and how is it prescribed?
Vyloy is given as an intravenous infusion (into a vein) every 2 or 3 weeks, depending on the chemotherapy regimen.
- The initial dose is 800 mg/m², followed by a maintenance dose of 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks.
- Before each infusion, patients receive medications to prevent nausea and vomiting.
- Treatment continues until the cancer progresses or side effects become intolerable.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for BLA 761365]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf. Accessed 2024 Nov 21.
