Is Lisocabtagene maraleucel approved by the FDA?

Lisocabtagene maraleucel, marketed under the brand name Breyanzi, is an innovative immunotherapy used to treat large B-cell lymphoma in adults. Lisocabtagene maraleucel received approval from the U.S. Food and Drug Administration (FDA) on February 5, 2021. This approval provides a new, critical option for patients with this aggressive form of lymphoma who have limited treatment alternatives.

Uses and Administration

Uses:

• Lisocabtagene maraleucel is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Administration:

• The treatment process involves a procedure called leukapheresis, where a patient's white blood cells are collected and sent to a laboratory to be modified into lisocabtagene maraleucel.
• Patients are pre-treated with chemotherapy to prepare their bodies for the infusion.
• The modified cells are then infused back into the patient through an intravenous suspension.
• The treatment is administered in an authorized hospital or clinic by healthcare professionals specially trained in handling this complex therapy.
• Patients need to remain near the treatment facility for at least four weeks post-infusion to monitor for side effects and ensure proper recovery.

Precautions and Considerations

Before Taking Lisocabtagene Maraleucel:

• Inform your doctor of any history of hepatitis B or C, as the treatment can reactivate these viruses.
• Discuss any recent vaccinations, as certain vaccines may not be advisable.
• Pregnant or breastfeeding women should consult their healthcare provider, and a negative pregnancy test may be required before starting the treatment.
• Patients must be aware of an increased risk of secondary cancers.

Potential Side Effects:

• Common Side Effects: headache, dizziness, confusion, fever, chills, nausea, vomiting, stomach pain, diarrhea, constipation, fast or irregular heartbeats, cough, trouble breathing, swelling, and pain in bones, joints, or muscles.
• Serious Side Effects: cytokine release syndrome (CRS), which can cause fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, and severe fatigue. Immediate medical attention is required if these symptoms occur.

Patients should report any side effects to their doctor and can also report to the FDA at 1-800-FDA-1088.

Important Considerations Post-Treatment

• Patients should avoid driving or operating heavy machinery for at least eight weeks after treatment due to potential side effects like weakness, drowsiness, confusion, and coordination issues.
• Avoid donating blood, organs, tissues, or cells for transplantation after receiving lisocabtagene maraleucel.

Conclusion

This advanced therapy offers hope for patients with limited options, marking a significant step forward in cancer immunotherapy. As with any potent medication, it comes with specific administration protocols and potential side effects, emphasizing the importance of careful monitoring and professional healthcare support throughout the treatment process.

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