News

The U.S. Food and Drug Administration has ordered Bristol-Myers Squibb to put a hold on three clinical trials evaluating Opdivo (nivolumab) in combination with immunomodulatory drugs as a treatment for multiple myeloma. Myeloma patients’ deaths in trials of Keytruda (pembrolizumab)-based combinations prompted the FDA crackdown on studies of immune…

The U.S. Food and Drug Administration (FDA) suspended a Phase 1 clinical trial testing a combination of AstraZeneca‘s Imfinzi (durvalumab) with an immunomodulatory and an anti-cancer therapy for multiple myeloma. The agency also placed a partial hold on five additional trials testing similar Imfinzi combinations in myeloma and other blood cancers.

New long-term data from the Phase 3 ENDEAVOR trial has shown that relapsed multiple myeloma patients treated with Kyprolis (carfilzomib) plus dexamethasone survive a median of nine months longer than those who received Velcade (bortezomib) and dexamethasone, Amgen announced. The newly-reported 24 percent reduction in the risk of death is even higher…

Relapsed multiple myeloma patients who receive Kyprolis (carfilzomib) plus dexamethasone as their second-to-fourth treatment regimen survive a median of 7.6 months longer than those given Velcade (bortezomib) and dexamethasone, new data from the ENDEAVOR trial (NCT01568866) has shown. In a head-to-head comparison, the ENDEAVOR study is the…

Patients with relapsed or treatment-resistant multiple myeloma, who have undergone several earlier treatment rounds, have a much poorer response to combination treatments including Darzalex (daratumumab) than what has been reported in clinical trials, according to an analysis by the Mayo Clinic. Nevertheless, the research team underscored that Darzalex-containing combination…

Newly-diagnosed multiple myeloma patients who are not eligible for a stem cell transplant reduce the risk of disease progression or death by half when Darzalex (daratumumab) is added to the combination of Velcade (bortezomib), melphalan, and prednisone, an interim analysis of a Phase 3 trial has revealed. The study, called ALCYONE (…

BioLineRx is seeking regulatory approval to advance into a Phase 3 clinical trial its treatment BL-8040, for blood stem cell mobilization to prepare for autologous transplants in patients with multiple myeloma. The company hopes that the trial, called GENESIS, will allow BL-8040 to become an approved treatment for myeloma. The…

Kite Pharma has submitted an investigational new drug application to the U.S. Food and Drug Administration that would pave the way toward clinical trials of its myeloma therapy KITE-585. The agency must approve the application before Kite can begin testing the therapy in people with relapsed or refractory multiple myeloma. KITE-585 is a…

Combining the proteasome inhibitor Kyprolis (carfilzomib) with dexamethasone is beneficial for adult patients with multiple myeloma who have received at least one prior therapy, the Scottish Medicines Consortium (SMC) determined. The SMC advises the Scottish National Health Service (NHS) boards…

Myeloma patients who received a single dose of the investigational therapy CLR 131 in an ongoing Phase 1 clinical trial have reached a median overall survival of 22 months, according to the drug’s developer, Cellectar Biosciences. Cellectar is a clinical stage biotech developing phospholipid-drug conjugates (PDCs) for use in anti-cancer therapies.