News

C4 Therapeutics Readying to Open Phase 1/2a Trial of CFT7455

C4 Therapeutics is preparing to launch a clinical trial testing its lead investigational therapy CFT7455 in multiple myeloma and other blood cancers. The U.S. Food and Drug Administration (FDA) approved the company’s application requesting a Phase 1/2a trial, which could open by mid-year. “With FDA clearance achieved, we…

Xpovio Approved in Israel for Some Myeloma, Lymphoma Patients

The Israeli Ministry of Health has approved Xpovio (selinexor), in combination with the corticosteroid dexamethasone, for the treatment of people with multiple myeloma who have received three or more prior therapies, and who failed to respond to at least one immunomodulatory agent, one proteasome inhibitor, and one CD38…

FDA Clears Way for Clinical Trial of HDP-101

Heidelberg Pharma has been cleared in the U.S. to begin a clinical trial testing its investigational therapy HDP-101 for the treatment of multiple myeloma. The U.S. Food and Drug Administration (FDA) allowed the start of a Phase 1/2a trial following the submission of an investigational new drug…

Under-the-skin Velcade Found to Work Better in Farydak Triple Combo

Using an under-the-skin formulation of Velcade (bortezomib), in combination with Farydak (panobinostat) and oral dexamethasone, leads to a better safety profile in people with relapsed or refractory (resistant) multiple myeloma than does the therapy’s original into-the-vein version, data show. The triple combination treatment with under-the-skin Velcade also was…

EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma

An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process…

EU Committee Supports Nexpovio for Heavily Treated Myeloma Patients

A combination of Nexpovio (selinexor) and the corticosteroid dexamethasone has been recommended for conditional approval in the European Union to treat adults with relapsed or refractory multiple myeloma who received at least four prior therapies. This includes patients whose disease failed to respond to at least two proteasome inhibitors,…