Johnson & Johnson Moves Tecvayli Earlier in Europe After FDA Myeloma Nod

Johnson & Johnson Moves Tecvayli Earlier in Europe After FDA Myeloma Nod

Johnson & Johnson filed with the European Medicines Agency to expand Tecvayli’s use as a solo treatment for adults with relapsed or refractory multiple myeloma after one prior therapy. The filing follows U.S. approval of Tecvayli with Darzalex last week and is supported by a phase 3 trial showing Tecvayli reduced disease progression or death by 71% versus standard care. The post Johnson & Johnson Moves Tecvayli Earlier in Europe After FDA Myelom…

TECVAYLI®▼ (teclistamab) Monotherapy Application Submitted to the EMA for Relapsed/refractory Multiple Myeloma after at least One Prior Yherapy - Life Sciences British Columbia

Johnson & Johnson  announced the submission of a Type II variation application to the European Medicines Agency (EMA).

FDA approves Tecvayli-Darzalex Faspro combo to treat myeloma

The U.S. Food and Drug Administration (FDA) has approved the combination of Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for treating certain people with multiple myeloma. The approval specifically covers myeloma patients whose cancer didn’t respond to (refractory), or came back following (relapsed), at least one prior line of treatment. The milestone was announced by Johnson & Johnson (J&J), which markets both…