Lisocabtagene Maraleucel
Lisocabtagene maraleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy used to treat certain adults with relapsed or refractory B-cell non-Hodgkin lymphomas, including specific types of large B-cell lymphoma and chronic lymphocytic leukaemia/small lymphocytic lymphoma, depending on the approved indication and treatment history. It is manufactured by collecting a patient’s own T cells, genetically modifying them to recognise CD19 on malignant B cells, and reinfusing them to target and destroy cancer cells. The therapy is supplied as a patient-specific intravenous cell suspension and is administered at specialised treatment centres following lymphodepleting chemotherapy. Serious adverse effects include cytokine release syndrome (CRS), neurological toxicity or immune effector cell-associated neurotoxicity syndrome (ICANS), infections, prolonged low blood-cell counts, and hypogammaglobulinaemia. Patients require close monitoring during and after infusion, with facilities available to manage severe immune-related complications. Lisocabtagene maraleucel should be administered only by qualified specialists under the applicable regulatory and product-specific protocols.
Lisocabtagene Maraleucel was historically used as a respiratory medicine for the symptomatic management of certain respiratory conditions. Its former uses included:
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The import of medicines into India is regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The regulatory requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished formulation, or an unapproved medicine intended for an individual patient's treatment.
Primeera Healthcare Private Limited can provide import coordination and pharmaceutical documentation assistance for Lisocabtagene Maraleucel, subject to confirmation of its current regulatory status and eligibility for import into India.
The export of Lisocabtagene Maraleucel from India is subject to applicable requirements under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and relevant export, customs, and destination-country regulations. Documentation requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished pharmaceutical formulation, or a medicine intended for a specific market. Export eligibility and destination-country requirements must be verified before shipment.
Primeera Healthcare Private Limited can provide pharmaceutical export documentation assistance, regulatory coordination, and shipping support for Lisocabtagene Maraleucel, subject to confirmation of its export eligibility under applicable Indian regulations and the import requirements of the destination country.
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