Shots: The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the […]Read More
Tags : tisagenlecleucel
Regulatory
Novartis’ Kymriah (tisagenlecleucel) Receives the US FDA’s Regenerative Medicine Advanced
Shots: Shots: The US FDA has granted RMAT designation to Novartis’ Kymriah (tisagenlecleucel) to treat patients with r/r FL. The designation is based on P-II ELARA study evaluating the efficacy and safety of tisagenlecleucel in adult patients with r/r FL The RMAT designation supports the advancement of Kymriah and reflects the unmet need for patients […]Read More