Shots:

• The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT- an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
• The study demonstrated an OR rate (93 %) with CR (67%)- as assessed by an Independent RRC following a single infusion. In safety analyses- Grade 3 or higher CRS and neurologic events in 15% and 33% of patients
• Tecartus is the first CAR T therapy in r/r MCL. With the approval- Kite becomes the first company with multiple approved cell therapies in the EU

 ­ Ref: Businesswire | Image: Glassdoor