Experiences with

Yescarta

The notice and investigation pertain to all currently approved BCMA- and CD19-targeted CAR T-cell products:[/i] [i] Axicabtagene ciloleucel (Yescarta)[/i] [i] Brexucabtagene autoleucel (Tecartus)[/i] [i] Ciltacabtagene autoleucel (Carvykti)[/i] [i] Lisocabtagene maraleucel (Breyanzi)[

These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™, Yescarta

These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™, Yescarta

Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or Yescarta) should consider themselves immunosuppressed even if it has been more than two years from their treatment.

Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or Yescarta) should consider themselves immunosuppressed even if it has been more than two years from their treatment.

[i]Patients with relapsed chronic lymphocytic leukemia (CLL) and B-cell lymphoma who received the anti-CD19 CAR T-cell therapy FMC63-28Z, which was later developed as axicabtagene ciloleucel (axi-cel; Yescarta), experienced highly durable rates of remission, according to long-term data from a phase 1

The approval was based on findings from the phase II JULIET study, updated data of which showed an overall response rate (ORR) of 52%, with a complete response (CR) rate of 40%.1 - Previously, the FDA approved the CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) in October 2017 as a treatment