Cell and Gene Therapies Saw Banner Year with New Indications on the Horizon

In terms of approvals of new products, 2021 was the second-best year for cell and gene therapies and tissue products (The best year was 2016, when nine therapies were approved.).

This year, six such therapies were approved by regulators. FDA approvals included Bristol Myers Squibb’s (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma, BMS’ Breyanzi (lisocabtagene maraleucel) for third-line treatment of large B-cell lymphoma and Mallinckrodt’s Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for treatment of burns.

The FDA also approved Enzyvant Therapeutics’ Rethymic (allogeneic processed thymus tissue-agdc) for pediatric congenital athymia.