As of 2025, seven CAR-T cell therapies have been approved by the FDA. These treatments are developed by major pharmaceutical companies and are used to treat certain blood cancers. The approved therapies are:

FDA-Approved CAR-T Therapies (as of 2025)

  1. Abecma™ (idecabtagene vicleucel) – Idacel
    • Company: Bristol Myers Squibb / 2seventy bio
    • Indication: Multiple Myeloma
  2. Carvykti™ (ciltacabtagene autoleucel) – Ciltacel
    • Company: Janssen (J&J) / Legend Biotech
    • Indication: Multiple Myeloma
  3. Kymriah™ (tisagenlecleucel) – Tisa-cel
    • Company: Novartis
    • Indication: Pediatric ALL, DLBCL
  4. Yescarta™ (axicabtagene ciloleucel) – Axi-cel
    • Company: Kite Pharma (Gilead)
    • Indication: B-cell lymphomas
  5. Tecartus™ (brexucabtagene autoleucel) – Brexu-cel
    • Company: Kite Pharma (Gilead)
    • Indication: Mantle Cell Lymphoma, Adult ALL
  6. Breyanzi™ (lisocabtagene maraleucel) – Liso-cel
    • Company: Bristol Myers Squibb
    • Indication: Large B-cell Lymphoma, CLL/SLL
  7. AuctaZil™ (obecabtagene autoleucel) – Obeca-cel
    • Company: BioNTech (in collaboration with Autolus)
    • Indication: Acute Lymphoblastic Leukemia (ALL)

These commercial CAR-T therapies involve extracting T cells from a patient’s blood, shipping them to a centralized manufacturing facility (often overseas), modifying the cells, and shipping them back in a frozen state to the hospital for reinfusion. This process, known as "vein-to-vein" time, can take between 1-2 months.

What is Point-of-Care CAR-T Therapy?

Unlike commercial CAR-T therapies, a new method called Point-of-Care (POC) CAR-T therapy, also referred to as "in-house" or "home-grown" CAR-Ts, has emerged globally. In this approach, the CAR-T cells are manufactured locally within the hospital's laboratories. This reduces the vein-to-vein time significantly, as the cells can be collected, processed, and reinfused into the patient within 10-12 days.

This process is made possible by equipping hospitals with state-of-the-art cell therapy laboratories, often developed in collaboration with specialized biotech companies experienced in cell therapy manufacturing.

What are the Advantages of Point-of-Care CAR-T Therapy?

Point-of-Care CAR-T therapy offers several advantages:

  1. Faster Treatment: POC CAR-Ts are available to patients in as little as 10-12 days, compared to the 1-2 months required for commercial CAR-Ts.
  2. Affordability: POC CAR-T therapies are significantly more cost-effective, making them a viable option for international patients paying out of pocket.
  3. Preserved Cell Quality: Since the cells are processed locally without the need for long-distance shipping and freezing, the quality of the modified T cells is maintained.
  4. Effectiveness: Studies have shown that POC CAR-T therapies are as effective as commercially manufactured options, provided the hospital has the necessary expertise and experience.

Comparison of Point-of-Care CAR-T vs. Commercial CAR-T

Point-of-Care CAR-T

  • Conducted directly in the hospital.
  • Cell quality is preserved due to local processing.
  • Vein-to-vein time: 10-12 days.
  • Significantly more affordable for international patients.

Commercial CAR-T:

  • Requires shipping blood and cells overseas for processing.
  • Cell quality may be impacted by freezing and transport.
  • Vein-to-vein time: 1-2 months.
  • Costs range from $200,000 to $500,000 USD, depending on the country.

Point-of-Care CAR-T therapy is an exciting advancement in personalized medicine, offering faster, more accessible, and affordable treatment options while maintaining high success rates. Patients are encouraged to explore their options and consult with experienced hospitals to determine the best treatment plan.



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