Novartis Advances Kymriah into New Indication with RMAT Designation and Reports Positive Phase 3 REACH2 Data for Jakavi in Steroid-Refractory Acute GvHD

On April 22 local time, Novartis announced the Phase III REACH2 study data for Jakavi, which demonstrated improved outcomes in patients with steroid-refractory acute graft-versus-host disease (GvHD) who had failed first-line therapy. The relevant data were published in The New England Journal of Medicine.

The phase III REACH2 study results showed that at the primary endpoint on Day 28, the overall response rate for Jakavi treatment was 62%, compared to 39% for the best available therapy. Additionally, no new adverse reactions were observed in the REACH2 study, and treatment-emergent adverse events were consistent with the known safety profile of Jakavi. The most common adverse reactions were thrombocytopenia, anemia, and cytomegalovirus infection.

On the same day, Novartis also announced that the U.S. Food and Drug Administration (FDA) had granted Kymriah Regenerative Medicine Advanced Therapy (RMAT) designation for investigating a new indication in patients with relapsed or refractory follicular lymphoma.

Kymriah is the first globally approved CAR-T cell therapy. The potential approval for relapsed or refractory follicular lymphoma would mark the third indication for Kymriah, which is also indicated for relapsed or refractory acute lymphoblastic leukemia in children and young adults, as well as relapsed or refractory diffuse large B-cell lymphoma in adults.

Reference Sources:

1、Novartis announces data showing Jakavi® (ruxolitinib) more effective than best available therapy in acute graft-versus-host disease

2、Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

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