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Benzinga
Benzinga
Technology
Vandana Singh

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 (NYSE:NVSKymriah (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.
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