Kite Reports the Validation of EMA’s MAA for KTE-X19 to Treat Relapsed or Refractory Mantle Cell Lymphoma

 Kite Reports the Validation of EMA’s MAA for KTE-X19 to Treat Relapsed or Refractory Mantle Cell Lymphoma

Kite Reports the Validation of EMA’s MAA for KTE-X19 to Treat Relapsed or Refractory Mantle Cell Lymphoma

Shots:

  • The MAA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with MCL whose diseases is refractory & relapsed following up to five prior therapies including anthracycline/ bendamustine-containing CT, anti-CD20 mAb and the BTK inhibitors (ibrutinib/ acalabrutinib)
  • The P-II ZUMA-2 study results: ORR (93%); CR (67%) as assessed by IRRC following a single infusion of KTE-X19 (median follow-up of 12.3mos.). Following the approval, KTE-X19 would be the first CART cell therapy for MCL
  • KTE-X19 is an investigational, autologous, anti-CD19 CART cell therapy, being evaluated in P-I/II study in ALL, MCL and CLL and has received FDA’s BT and EMA’s PRIME designation. On Dec 11, 2019, Kite has submitted BLA to the US FDA for the therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Biobuzz

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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