Patricia Inácio, PhD, science writer —

The U.S. Food and Drug Administration has allowed Fortis Therapeutics’ antibody-drug conjugate FOR46 to begin testing in a Phase 1 clinical trial as a therapy for late-stage multiple myeloma. The trial (NCT03650491), scheduled to begin in early 2019, estimates to enroll 50 myeloma patients who have failed prior…

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb‘s Empliciti (elotuzumab), in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, as a treatment for patients with relapsed or treatment-resistant multiple myeloma. The approval covers patients whose disease progressed despite treatment with at least two therapies, including Celgene‘s Revlimid (lenalidomide) and…

Myeloma Crowd has launched an online tool called HealthTree, aimed at helping patients with multiple myeloma find the most appropriate therapies for their condition, while boosting research toward a potential cure for multiple myeloma. By registering with HealthTree, which is free, patients can track their body’s response to different…

Amgen is seeking to expand the approval of its proteasome inhibitor Kyprolis (carfilzomib) in the U.S. to include once-weekly dosing combined with dexamethasone for multiple myeloma patients with hard-to-treat disease or whose disease relapsed. The company used data from its Phase 3 ARROW trial as the basis for its…

The U.S. Food and Drug Administration granted priority review to Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) combined with Pomalyst (pomalidomide) and low-dose dexamethasone as a treatment for patients with relapsed or treatment-resistant multiple myeloma. The application covers patients whose disease has progressed despite treatment with at least two…

The U.S. Food and Drug Administration has granted orphan drug status to SRF231 to treat multiple myeloma, according to Surface Oncology, which is developing the investigational therapy. Orphan drug designation aims to assist in developing therapies for rare and serious diseases that have a high unmet need by providing…

Expanded use of Darzalex (daratumumab) in combination with standard therapy for treating adult patients with newly-diagnosed multiple myeloma, and who are not candidates for stem cell transplant, has been recommended by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). The recommendation is based on results from the…

Takeda‘s proteasome inhibitor Ninlaro (ixazomib) prevents multiple myeloma from progressing or returning when given as a maintenance therapy to patients who responded to first-line therapy and stem cell transplant, a Phase 3 clinical trial shows. The trial, called TOURMALINE-MM3 (NCT02181413), compared Ninlaro to placebo in newly-diagnosed patients given standard induction therapy…

Adding Empliciti (elotuzumab) to a combination of Pomalyst (pomalidomide) and dexamethasone significantly delays disease worsening or death in myeloma patients who failed to respond to previous treatment, data from the Phase 2 ELOQUENT-3 trial show. These results were recently shared at the 23rd European Hematology Association (EHA) Congress in Stockholm, in a presentation titled…

While the best described cancer mutations are in regions that provide instructions to make proteins, most mutations actually happen in the noncoding regions of our genome, researchers found. University of California researchers identified 200 new mutations in noncoding DNA that drive tumor formation and growth. Their findings may lead to…