FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Novartis’ Kymriah Prioritized for Review in U.S., Europe

Jan. 23, 2018
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The FDA and EMA agreed to grant a fast-track review to Novartis’ gene therapy Kymriah, the Swiss drugmaker reported.

The FDA granted the therapy priority review for use in treating adults who are ineligible for or relapse after an autologous stem cell transplant (ASTC).

In the EU, the EMA granted the gene therapy an accelerated assessment for children and young adults with r/r B-cell ALL and adults with r/r DLBCL who are ineligible for ASTC.

The applications are based on data from a global clinical trial of Kymriah sponsored by Novartis. The trial, involving children and young adults with r/r B-cell ALL and adults with r/r DLBCL, demonstrated the therapy’s efficacy and safety across studies.

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