EU Approves First Chikungunya Vaccine, Expands Approval for Liso-cel
February 05, 2025
The European Union’s Committee for Medicinal Products for Human Use (CHMP) announced several approvals related to vaccines and biotherapies on Jan. 31.
New Cellular Therapy for FL
The CHMP
recommended expanding the marketing authorization for lisocabtagene maraleucel (liso-cel), to include adults with relapsed or refractory follicular lymphoma (FL) after at least two lines of systemic therapy. The approval was based on findings from the
phase 2 TRANSCEND trial, in which 97.1% of patients achieved a response and 74.2% achieved a complete response.
Liso-cel, marketed as Breyanzi by Bristol Myers Squibb, is
now indicated in the EU for multiple types of relapsed or refractory lymphoma after two or more lines of therapy.
Europe’s First CHIKV Vaccine
The CHMP also
recommended granting marketing authorization for the first Chikungunya virus (CHIKV) vaccine in the EU. Marketed as Vimkunya by Bavarian Nordic, the vaccine is administered as a single dose and is approved for use in individuals ages 12 and older.
CHIKV, a mosquito-borne virus, is endemic to sub-Saharan Africa, India, Southeast Asia and the Philippines, with outbreaks also reported in other regions, including Italy. While CHIKV is theoretically transmissible through blood transfusion, no documented cases have been reported. More information is available in AABB’s
CHIKV fact sheet.
