logo
Plus   Neg
Share
Email

FDA Approves Kite's Tecartus For Relapsed Or Refractory Mantle Cell Lymphoma Treatment

Kite, a Gilead Company (GILD), said that the U.S. Food and Drug Administration has granted accelerated approval to Tecartus, the first and only approved chimeric antigen receptor or CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma or MCL.

The approval of the one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR).

The company noted that 18 percent experienced Grade 3 or higher cytokine release syndrome (CRS) and 37 percent experienced Grade 3 or higher neurologic toxicities.

Tecartus has a Boxed Warning in its product label regarding the risks of CRS and neurologic toxicities. A Risk Evaluation and Mitigation Strategy (REMS) has been approved by the FDA for Tecartus and has been combined with the Yescarta (axicabtagene ciloleucel) REMS.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Amid the growing climate crisis, Walmart said it is raising its ambition to zero emissions by 2040, without the use of carbon offsets, across its global operations. The retail giant, along with the Walmart Foundation, also committed to help protect, manage or restore at least 50 million acres of land and one million square miles of ocean by 2030. The European Commission said Friday that it has signed a deal with Sanofi and GlaxoSmithKline to secure up to 300 million doses of their potential COVID-19 vaccine. Acella Pharmaceuticals recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency, the U.S. Food and Drug Administration said in a statement. The company is recalling one lot of 15mg and one lot of 120mg of NP Thyroid that are packaged in 100 count bottles in strengths of 15 mg, and 120 mg, with expiration dates between October 2020 and November 2020.
Follow RTT