Yescarta has received European marketing authorization for the treatment of relapsed or refractory diffuse large B-cell lymphom and primary mediastinal large B-cell lymphoma
The European Commission ( EC ) has granted Marketing Authorization for Yescarta ( Axicabtagene ciloleucel ) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) and primary mediastinal large B-cell lymphoma ( PMBCL ), after two or more lines of systemic therapy.
Axicabtagene ciloleucel is a chimeric antigen receptor T cell ( CAR-T ) therapy, which harnesses a patient’s own immune system to fight certain types of blood cancer.
The cell therapy has been proven to induce complete response ( no detectable cancer ) in a proportion of patients with relapsed or refractory DLBCL and PMBCL, which are aggressive forms of non-Hodgkin lymphoma ( NHL ).
The Marketing Authorization Application ( MAA ) is supported by data from the ZUMA-1 trial of Axicabtagene ciloleucel in adult patients with refractory aggressive NHL.
In the single-arm trial, 72% of patients ( n=73/101 ) who received a single infusion of Axicabtagene ciloleucel responded to therapy, with 51% ( n=52/101 ) achieving a complete response ( as assessed by an independent review Committee, median follow-up of 15.1 months ).
At one year following infusion, 60% of patients were alive ( 95% CI: 50.2, 69.2 ) and the median overall survival ( OS ) had not been reached ( 95% CI: not estimable [ NE ] ).
Axicabtagene ciloleucel may cause side effects that are severe or life threatening, such as cytokine release syndrome ( CRS ) or neurological toxicities.
In ZUMA-1, 12% of patients experienced grade 3 or higher cytokine release syndrome and 31% experienced grade 3 or higher neurologic toxicities.
Overall 98% of patients recovered from cytokine release syndrome and/or neurologic adverse reactions.
Treatment algorithms have been developed to manage some of the symptoms associated with both cytokine release syndrome and neurologic adverse reactions experienced by patients on Axicabtagene ciloleucel.
The most common grade 3 or higher adverse reactions include encephalopathy, unspecified pathogen infection, cytokine release syndrome, bacterial infection, aphasia, viral infection, delirium, hypotension and hypertension. ( Xagena )
Source: Gilead, 2018