European Commission grants conditional approval to Tecartus for relapsed or refractory mantle cell lymphoma. Kite/Gilead
Read time: 1 mins
Published:17th Dec 2020
Kite, a Gilead Company announced that the European Commission has granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available. The conditional marketing authorization is supported from the multinational, single-arm, Phase II open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.
Condition: Mantle Cell Lymphoma
Related news and insights
Keytruda + chemotherapy significantly improved progression-free survival compared to chemotherapy alone as first-line therapy for advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.- Merck Inc.,
Merck Inc., known as MSD outside of the United States and Canada, announced results from the Phase III NRG GY018 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR).