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The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. View funders.

2017-05-31T15:56:02.000Z

The FDA grants KTE-C19 Priority Review for the treatment of transplant-ineligible relapsed/refractory Non-Hodgkin Lymphoma

May 31, 2017
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On 26th May 2017, KTE-C19 (axicabtagene ciloleucel) was granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of patients who are ineligible for transplant with R/R NHL.

Results of the phase II ZUMA-1 trial (NCT02348216) form the basis of this Priority Review. Preliminary data from the ZUMA-1 trial were presented in April during AACR 2017, which the Lymphoma Hub reported on.

As a result of this Priority Review, a decision on Kite Pharma’s Biologics License Application (BLA; submitted in March 2017) for KTE-C19 will be reached 4 months earlier than if under standard review.

Kite Pharma also plan to file for potential approval for KTE-C19 in Europe for R/R DLBCL patients; this application is expected to take place in Q3 of this year.

  1. Targeted Oncology. KTE-C19 Granted Priority Review by FDA for Non-Hodgkin Lymphoma. 2017 May 26. http://www.targetedonc.com/news/ktec19-granted-priority-review-by-fda-for-nonhodgkin-lymphoma. [Accessed 2017 May 30].

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