U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Relapsed or ...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application for iberdomide combined with Darzalex ...
The FDA has started a priority review of iberdomide as an add-on to Johnson & Johnson and Genmab's anti-CD38 antibody Darzalex (daratumumab) and dexamethasone, a standard regimen for relapsed or ...
Minimal residual disease (MRD) refers to the small number of myeloma cells that may remain after treatment and are not detectable using conventional response criteria. In multiple myeloma, MRD ...
Genetically modified immune cells can offer precious additional time to patients with advanced multiple myeloma. However, these therapies lose their impact as the molecules on cancer cells that immune ...
Bristol Myers Squibb BMY announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate, iberdomide, in combination with standard therapies (daratumumab and ...
The NDA is supported by data from the EXCALIBER-RRMM trial, which evaluated the safety and efficacy of iberdomide, an investigational cereblon E3 ligase modulator.
Hepta refractory multiple myeloma is marked by antigen loss, genomic complexity, and 12.8 month median survival in multi centre data.
Multiple myeloma was once viewed as an incurable diagnosis, but Ameet Patel, MD, of Florida Cancer Specialists & Research ...
Bristol Myers Squibb said the U.S. Food and Drug Administration has granted priority review to its application seeking approval of its iberdomide drug candidate in certain patients with the blood ...
FDA has accepted the NDA for BMS's Iberdomide, an oral agent targetting relapsed/refractory multiple myeloma.
The proposed recommendations are intended to safely expedite approvals of promising therapies for multiple myeloma, but one expert is skeptical about the likelihood of industry compliance.