On 5 March 2021, axicabtagene ciloleucel received accelerated approval by the USFDA to treat adults suffering from relapsed or refractory follicular lymphoma (non-Hodgkin’s lymphoma).
The approval was given on the basis of the findings from the ZUMA-5 trial, a multicenter, single-arm, open-label trial that investigated axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T cell therapy, in adults having relapsed/refractory follicular lymphoma after two or more lines of systemic treatment, including the combo of an alkylating agent and anti-CD20 monoclonal antibody.
After lymphodepleting chemotherapy, a single intravenous infusion of axicabtagene ciloleucel was given. The major endpoints were
- duration of response
- objective response rate
Out of 81 participants in the primary assessment, the objective response rate was found to be 91% with a complete remission rate of about 60% and a median time-to-response of one month. The median duration of response was not attained, and the one-year rate of continued remission was 76.2%. The objective response rate was 89% with a complete remission rate of 62% for all the leukapheresed subjects in this trial (n=123),
Axicabtagene ciloleucel’s prescribing information has a warning for neurologic toxicities and cytokine release syndrome. In axicabtagene ciloleucel studies, it was noted that among all individuals suffering from non-Hodgkin’s lymphoma, cytokine release syndrome was found to occur in 88% (Grade ≥3, 10%) and neurologic toxicities were found to occur in 81% (Grade ≥3, 26%).
In individuals suffering from non-Hodgkin’s lymphoma, the most common non-laboratory adverse reactions (incidence ≥20%) are dizziness, constipation, cytokine release syndrome, fatigue, fever, febrile neutropenia, hypotension, tremor, encephalopathy, hypoxia, tachycardia,, headache, nausea, infections with pathogen unspecified, decreased appetite, chills, diarrhea, musculoskeletal pain, arrhythmias, cough, and vomiting.
FDA has also approved crizotinib to treat refractory or relapsed, systemic anaplastic large cell lymphoma (a rare type of non-Hodgkin lymphoma).
|Link:||https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-axicabtagene-ciloleucel-relapsed-or-refractory-follicular-lymphoma [Last accessed on: 17 April, 2021]|
|Original title of the article||FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma|