Tecvayli: Approved by the FDA for blood cancer treatment
The US FDA granted accelerated approval on October 25, 2022, to the drug teclistamab-cqyv, which is sold under the brand name Tecvayli for the treatment of relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Tecvayli is supplied in injection in 30 mg/3 mL and 153 mg/1.7 mL for subcutaneous infusion.
Multiple myeloma is one of the blood cancers that forms in a white blood cell called a plasma cell. Healthy plasma cells help a person fight infections by making antibodies that recognize and attack germs. Rather than produce helpful antibodies, the cancer cells produce abnormal proteins that can cause complications.
Healthcare professionals recommend administering Tecvayli doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. One should administer pretreatment medications before each dose of the Tecvayli step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as per the prescribing information of Tecvayli.
Common Side effects
The common side-effects of Tecvayli are:
- Pyrexia
- Cytokine release syndrome
- Musculoskeletal pain
- Injection site reaction
- Fatigue
- Upper respiratory tract infection
- Nausea
- Headache
- Pneumonia
- Diarrhea
Mechanism of Action
Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen expressed on the surface of cells affected by multiple myeloma and some healthy B-lineage cells. In clinical studies, teclistamab-cqyv activated T-cells caused the release of various proinflammatory cytokines and lysis multiple myeloma cells.
Reference: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf
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- On November 4, 2022
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