Joana Carvalho, PhD, managing science editor —

The U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) of Darzalex (daratumumab) in combination with standard pre-transplant therapy for the treatment of patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant…

Oncopeptides is preparing to submit a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) to seek accelerated approval of Ygalo (melflufen) to treat patients with triple-refractory multiple myeloma. Ygalo is a lipophilic peptide-conjugated alkylator that works by rapidly delivering a…

ALLO-715, Allogene Therapeutics‘ donor-derived CAR T-cell therapy, can trigger a durable anti-tumor response in mice with multiple myeloma, and maintain its characteristics and anti-tumor activity after large-scale manufacturing, a study says. The preclinical findings were reported in the study, “Preclinical Evaluation of Allogeneic CAR T Cells Targeting…

Maintenance therapy with Ninlaro (ixazomib) can prolong and boost therapeutic responses from initial treatment in multiple myeloma patients who did not undergo an autologous stem cell transplant, a study says. The study, “Ixazomib maintenance therapy in newly diagnosed multiple myeloma: An integrated analysis of four phase I/II…

The European Medicines Agency‘s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Celgene‘s Revlimid (lenalidomide) and Pomalyst (pomalidomide, marketed as Imnovid in Europe) as combination therapies with Velcade (bortezomib) and dexamethasone for adult patients with…

CT053, one of CARsgen Therapeutics‘ lead CAR T-cell therapies, soon will begin clinical testing in China for the treatment of patients with relapsed or refractory multiple myeloma, after the Chinese National Medical Products Administration (NMPA) cleared its investigational new drug (IND) application. In recent years, immunotherapy has gained…

The U.S. Food and Drug Administration has raised concerns in its newly released briefing materials over the safety and tolerability of Karyopharm Therapeutics‘ lead compound selinexor, creating a potential stumbling block on its path to approval for heavily treated multiple myeloma. Selinexor is an oral inhibitor of the XPO1 protein that prevents…

Celgene‘s immunomodulatory agent Revlimid (lenalidomide) significantly extended the time until disease progression in patients with smoldering multiple myeloma who were not yet experiencing any symptoms of disease, according to Phase 2/3 results announced by the company. The open-label, randomized Phase 2/3 study (NCT01169337), led by the ECOG-ACRIN Cancer Research…

Adding Darzalex (daratumumab) to the standard pre-transplant therapy for multiple myeloma significantly increased the number of patients showing no signs of cancer after a stem cell transplant, a Phase 3 trial shows. The open-label, multicenter study, called CASSIOPEIA (NCT02541383), was designed to test Genmab‘s Darzalex in multiple…

Molecular Templates has partnered with Takeda to develop engineered toxin bodies (EBTs) — a next-generation immuno-oncology therapy that delivers toxic payloads to cancer cells — targeting the CD38 molecule as a potential treatment for multiple myeloma. The lead candidate is the result of a discovery from a previous collaboration study between the two…