The European Medicines Agency has validated Bristol-Myers Squibb’s application for Empliciti (elotuzumab), in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, for the treatment of adults with multiple myeloma. Validation confirms that the submission is complete and signals the beginning of the EMA’s review process. The company’s type-II variation…
Poseida Therapeutics’ CAR T-cell therapy candidate P-BCMA-101 is showing superior safety over alternatives and significant effectiveness in patients with relapsed or refractory multiple myeloma, according to early results of a Phase 1 trial. The company’s ongoing open-label Phase 1 trial (NCT03288493) is designed to analyze the…
The combination of two blood tests routinely ordered by general practitioners could speed the diagnosis of myeloma, according to a new study. The research, “Early detection of multiple myeloma in primary care using blood tests: a case–control study in primary care,” was published in the…
A combination of Idera Pharmaceuticals’s treatment candidate tilsotolimod plus Yervoy (ipilimumab) is able to reduce tumors in a group of patients with refractory metastatic melanoma, current results of an ongoing Phase 2 trial show. The multi-center ILLUMINATE-204 study (NCT02644967) is evaluating the safety and efficacy of tilsotolimod…
A combination of Darzalex (daratumumab) plus Kyprolis (carfilzomib) and dexamethasone is well-tolerated and may be effective in multiple myeloma patients who fail to respond to treatment with Revlimid (lenalidomide), data from a Phase 1b study suggests. Janssen will present updated data from its MMY1001 study (NCT01998971) at the 2018 American…
New York City firefighters exposed to the 9/11 World Trade Center (WTC) disaster are at greater risk for developing a condition called monoclonal gammopathy of undetermined significance (MGUS), which may lead to multiple myeloma, a study suggests. The study, “Multiple Myeloma and Its Precursor Disease Among…
Multiple myeloma patients who failed prior Revlimid (lenalidomide) treatment may benefit from a triple oral combo treatment with Ninlaro (ixazomib), Pomalyst (pomalidomide) and dexamethasone, the results of a Phase 1/2 clinical study suggest. The research, “Phase I/II trial of the oral regimen ixazomib, pomalidomide, and dexamethasone in relapsed/refractory…
A Phase 1/2 clinical trial testing an experimental T-cell therapy for the first time in human patients will begin in the coming weeks after receiving approval from the German regulatory authority, Medigene recently announced. The treatment, called MDG1011, will be tested in 92 patients with blood cancer, including acute…
Treatment of bone lesions in multiple myeloma patients with Amgen’s Xgeva (denosumab) may be expanded to European patients following a positive opinion from the E.U. regulatory entity Committee for Medicinal Products for Human Use (CHMP). Xgeva is the first fully human antibody that neutralizes the RANKL…
A combination treatment including Pomalyst (pomalidomide) significantly extended the time until disease progression or death in patients with relapsed or refractory multiple myeloma who were treated in a Phase 3 trial. That result was announced by Celgene, Pomalyst‘s maker, regarding the OPTIMISMM trial (NCT01734928), which assessed if adding Pomalyst to …
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