Tisagenlecleucel (Kymriah) under review to treat non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia.
Today, Novartis announced that the FDA has accepted the supplemental biologics license application for tisagenlecleucel (Kymriah) for adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for, or who relapse after, autologous stem cell transplant (ASCT), according to a press release.
The FDA has granted this application priority review designation.
Novartis also noted that the European Medicines Agency (EMA) granted accelerated assessment for tisagenlecleucel for pediatric patients and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and adults with r/r DLBCL who are ineligible for ASCT, according to the release.
If approved by the FDA and EMA, tisagenlecleucel would become the first CAR-T cell therapy approved for 2 types of non-Hodgkin lymphoma and B-cell ALL, according to Novartis.
Tisagenlecleucel was first approved in August 2017 for patients younger than 25 years with B-cell precursor ALL that is refractory or who have experienced multiple relapses.
"The first approval of a CAR-T therapy truly redefined the future of the cancer treatment landscape, and we are only at the beginning of this new era in cancer care," said Samit Hirawat, MD, head, Novartis Oncology Global Drug Development. "The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognized the potential of Kymriah to provide a much-needed therapeutic option for these patients with relapsed or refractory B-cell ALL and DLBCL. We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients."
The regulatory applications are based on positive data from the phase 2 JULIET clinical trial and from the phase 2 ELIANA clinical trial, according to the release.
The JULIET trial investigated tisagenlecleucel in adults with r/r DLCBL who were enrolled across 10 countries. Novartis previously reported these findings at the annual meeting of the American Society of Hematology.
The ELIANA trial evaluated tisagenlecleucel in adults with r/r DLCBL who were enrolled across the United States, Canada, Australia, Japan, and the European Union, according to the release.
Novartis also said they plan to submit applications for tisagenlecleucel in pediatric and young adult patients with r/r B-cell ALL and adults with r/r DLBCL in 2018.