Novartis Receives Positive CHMP Opinion For Kymriah In Follicular Lymphoma, Jakavi In GvHD

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Novartis AG's NVS Kymriah (tisagenlecleucel) for follicular lymphoma.

• The opinion covers a CAR-T cell therapy for treating adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
• The CHMP positive opinion is based on the Phase 2 ELARA trial results. Among patients treated with Kymriah, 86% had a response, including 69% who experienced a complete response (CR). 
• If approved, r/r FL would be the third indication for which Kymriah is available to patients in the European Union (EU). 
• The CHMP also backed the approval of Jakavi (ruxolitinib) for chronic graft versus host disease (GvHD).
• The recommendation covers Jakavi for patients aged 12 years and older with acute GvHD who have an inadequate response to corticosteroids or other systemic therapies. 
• If approved, Jakavi will be the first JAK1/2 inhibitor available for patients with GvHD in Europe.
• The CHMP positive opinion was based on data from the Phase 3 REACH2 and REACH3 studies. Jakavi demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent GvHD, respectively.
• Price Action: NVS shares are up 0.06% at $86.69 during the market session on the last check Friday.