The Swiss agency for therapeutic products has granted temporary approval for MorphoSys AG (NASDAQ:MOR) and Incyte Corp's (NASDAQ:INCY) Minjuvi (tafasitamab) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- The approval comes for Minjuvi combined with lenalidomide, followed by Minjuvi monotherapy for adult patients, after at least one prior line of systemic therapy, who are not eligible for autologous stem cell transplant (ASCT).
- The approval is based on the results from the L-MIND study results that showed a best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%.
- The median duration of response (mDOR) was 43.9 months after a minimum follow-up of 35 months (secondary endpoint).
- Related: Incyte - MorphoSys's Diffuse Large B-Cell Lymphoma Drug Wins European Approval.
- Tafasitamab plus lenalidomide combo demonstrated a clinically meaningful response, and the side effects were manageable.
- Incyte and MorphoSys share global development rights to tafasitamab.
- Incyte has exclusive commercialization rights to tafasitamab outside the U.S.
- Price Action: MOR shares are up 1.86% at $6.57 during the premarket session on the last check Wednesday. INCY shares closed 1.92% higher at $78.05 on Tuesday.
