Obecabtagene autoleucel (Aucatzyl – Autolus), a CD19-directed genetically modified autologous T cell immunotherapy, has been approved by the FDA for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. The CAR T-cell immunotherapy products tisagenlecleucel (Kymriah) and brexucabtagene auto-leucel (Tecartus) were approved earlier for the same indication.

The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B who have disease refractory to first-line chemoimmunotherapy, relapsed within 12 months of or after first-line chemoimmunotherapy, are not eligible for hematopoietic stem cell transplantation due to comorbidities or age, or have relapsed or refractory disease after ≥2 lines of systemic therapy. Breyanzi is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell products axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) are also FDA-approved for treatment of large B-cell lymphoma.

Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved for treatment of relapsed or refractory mantle cell lymphoma. Tecartus is an individualized cellular product prepared from the patients own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell immunotherapy tisagenlecleucel (Kymriah) was approved in 2017 for treatment of relapsed or refractory B-cell precursor ALL in patients ≤25 years old.

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

The FDA has approved axicabtagene ciloleucel (Yescarta – Kite) for treatment of adults with relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. It is the second CAR T-cell immunotherapy to become available in the US. Tisagenlecleucel (Kymriah), a CAR T-cell product previously approved for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≤25 years old, was recently also approved for relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy.

The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.

The FDA has approved tisagenlecleucel (Kymriah — Novartis), an individualized, genetically-modified cellular product, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≤25 years old. The patient's own T cells are genetically modified to express chimeric antigen receptors (CAR) and then reinfused. Kymriah is the first CAR T-cell immunotherapy to become available in the US. A CAR T-cell product for B-cell non-Hodgkin's lymphoma is expected to be approved soon.