Tag Archives: myeloma

FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition… Read More »

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma Print this page HORSHAM, Pa., May 1, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. Darzalex Faspro™ is approved in four regimens… Read More »

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma Print this page BRIDGEWATER, N.J., March 2, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least… Read More »

J&J’s Darzalex makes FDA history with another myeloma nod in new patients

Johnson & Johnson’s multiple myeloma drug Darzalex has another FDA nod in previously untreated patients under its belt—and this one is a first for a biologic. The FDA has approved Darzalex in combination with Takeda’s Velcade, thalidomide and dexamethasone (VTd) for new patients who are eligible for stem cell transplant, making it the first biologic… Read More »