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FDA-Approved Cell Therapies for Cancer (as of 2025)


Prepared by: DR. Fathi. Department of Cancer TBR. Pficell Academia


CAR-T Cell Therapies

Brand Name Target Antigen Approved Indications Company Manufacturing Time Cost (USD) Key Limitations
Kymriah CD19 B-ALL (pediatric), DLBCL (adults) Novartis ~3–4 weeks $475,000 Cytokine release syndrome (CRS), neurotoxicity
Yescarta CD19 DLBCL, PMBCL, FL Kite/Gilead ~2–3 weeks $373,000 CRS, neurotoxicity, relapse risk
Tecartus CD19 Mantle Cell Lymphoma (MCL) Kite/Gilead ~3–4 weeks $424,000 For aggressive lymphomas only
Breyanzi CD19 Large B-cell lymphoma Bristol Myers Squibb ~3 weeks $410,000 Requires lymphodepletion
Abecma BCMA Multiple Myeloma BMS/bluebird bio ~4–5 weeks $419,500 Only for heavily pretreated MM
Carvykti BCMA Multiple Myeloma Janssen/Legend ~5–6 weeks $465,000 Complex manufacturing; strict eligibility

 

Dendritic Cell Therapy

Brand Name Mechanism Indication Company Cost (USD) Notes
Provenge DCs primed with tumor antigens (PAP) Metastatic castration-resistant prostate cancer Dendreon $93,000 First FDA-approved cell-based cancer vaccine (2010)

 

TIL Therapy

Brand Name Mechanism Indication Company Status Cost Estimate Notes
Amtagvi Autologous TILs expanded ex vivo Unresectable or metastatic melanoma Iovance FDA-approved in 2024 $400,000–$500,000 First FDA-approved solid tumor TIL therapy

 

Comparative Summary

Parameter CAR-T Dendritic Cell (Provenge) TIL Therapy
Target Hematologic cancers Prostate cancer Solid tumors (melanoma)
Source Autologous T cells Autologous APCs Autologous TILs from tumor
Engineering Genetic (CAR via viral vector) No genetic modification Expansion only
Response Rate 50–90% Modest survival benefit 30–50% ORR
Toxicity High (CRS, neurotoxicity) Very low Moderate (IL-2-related)
Manufacturing Time 2–6 weeks 2–3 weeks 4–6 weeks
FDA Status Multiple approvals Approved (2010) Approved (2024)

 

Emerging Therapies

Type Indications Status
CAR-NK cells Leukemia, Lymphoma, Solid tumors Phase I/II
TCR-T cells Melanoma, Synovial Sarcoma Phase II (Breakthrough Designation)
Onco-MSCs GBM, Metastatic brain tumors Early clinical trials
iPSC-derived NK or T cells Refractory cancers Preclinical to early human trials

 

Clinical Takeaway

  • CAR-T therapies are the most successful in blood cancers and expanding to CD22 and dual-targets.

  • TIL therapy is promising for solid tumors including melanoma, cervical, and lung cancers.

  • Dendritic cell therapy is safe but modest in efficacy and scope.

  • Cell therapies are expensive, complex, and mainly autologous; off-the-shelf allogeneic options such as CAR-NK are under development.