CAR-T - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T - August 2020
Kite submitted supplemental biologics license application (sBLA) to the FDA for Yescarta in R/R indolent non-Hodgkin lymphoma
04 Sep 2020
Yescarta (Axicabtagene ciloleucel; CD19-targeting autologous T cell immunotherapy) – Gilead Sciences/ Kite Pharma
- Kite Pharma submitted a supplemental Biologics License Application (sBLA) to FDA for Yescarta for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy
- The sBLA submission is supported by data from the primary analysis of the Phase 2 ZUMA-5 trial
- If approved, Yescarta would be the first CAR-T therapy for patients with relapsed/refractory Follicular lymphoma and Marginal zone lymphoma
Yescarta on path to become the first CAR-T approved for relapsed/refractory follicular lymphoma and marginal zone lymphoma
Share this
CI Scientists Remarks:
- Yescarta is a CD19-directed genetically modified autologous CAR-T approved in US, EU for the treatment of adult patients with relapsed or refractory large B-cell lymphoma
- In Aug’17, Gilead Sciences acquired Kite Pharma for $11.9 Billion which transferred Kite Pharma’s broad CART portfolio to Gilead including Yescarta, which was under priority review in the US and expedited review in the EU at the time of acquisition
| Product | Indication | Sales (Global) |
| Yescarta(CD-19 CAR-T) | R/R large B-Cell Lymphoma (US and EU) | Q2’20 – $156M |
| Kymriah (CD-19 CAR-T) | B-Cell ALL, NHL (US and EU) | Q2’20 – $118M |
- With Yescarta having previously granted breakthrough therapy designation (BTD) by the FDA for these indications, we can expect an expedited review of this product
– Dr. Kowndinya, CI Scientists