Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma.
- If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021
Headquartered in Milano, Italy, Anemocyte is the world’s first company to identify as a Biotech Manufacturing Organization (BMO). The company’s Cell Therapy Platform supports the manufacturing of autologous and allogeneic products, its DNA Platform produces plasmid DNA for viral vector production, and its Gene Therapy Platform supports process development and implementation for non-viral gene modified cells.
