News Releases
FDA Grants Janssen Research & Development Breakthrough Therapy Designation for Daratumumab
Janssen Research & Development, LLC (Janssen) announced the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.
FDA Approves Subcutaneous Administration of Takeda Drug Velcade
The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application ( sNDA ) for Velcade ( bortezomib ).
Merck Announces Multiple Myeloma Drug Trial Results
Merck announced today that a Phase III study of Zolinza ( vorinostat ), for investigational use in combination with bortezomib in patients with progressive multiple myeloma , met its primary endpoint, demonstrating a 23 percent reduction in the risk of progression compared to the standard therapy of bortezomib (p=0.01).