Marisa Wexler, MS, senior science writer —

Janssen has submitted an application with the U.S. Food and Drug Administration (FDA) asking that talquetamab be approved to treat relapsed or refractory multiple myeloma. “We look forward to working closely with the FDA in their review of the talquetamab submission,” Peter Lebowitz, MD, PhD, global oncology…

The efficacy and safety of Blenrep (belantamab mafodotin) as a treatment for relapsed/refractory multiple myeloma (RRMM) in a real-world setting is similar to what has been reported in clinical trials, according to a study from Israel. “Response rate, duration of response and toxicity profile appear to be comparable to…

An advisory panel to the U.S. Food and Drug Administration (FDA) has overwhelmingly decided that the Phase 3 OCEAN clinical trial did not provide sufficient evidence to support Pepaxto (melphalan flufenamide) as a treatment for relapsed or refractory multiple myeloma (RRMM). Notably, while the FDA will consider the committee’s…

A combination of the investigational therapy teclistamab and the approved medication Darzalex (daratumumab) reduced the cancer burden for most people with relapsed or refractory multiple myeloma (RRMM) in a clinical trial. The patients in the study had received from two to 17 prior lines of therapy, with a median…

The European Commission has granted full approval to a triple combination therapy of Nexpovio (selinexor) — sold in the U.S. as Xpovio —  to treat adults with multiple myeloma who have received at least one previous line of therapy. The approval covers Nexpovio in combination with Velcade (bortezomib)…

A branch of the European Medicines Agency (EMA) has recommended that Janssen’s investigational therapy Tecvayli (teclistamab) be granted conditional marketing authorization for adults with relapsed and refractory multiple myeloma (RRMM). The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), specifically supports Tecvayli for patients…

CYT-338, an investigational myeloma therapy designed to simultaneously bind to cancer cells and activate immune cells called natural killer cells, has shown promising anti-cancer activity in preclinical studies. A team led by scientists at Cytovia Therapeutics, the company developing CYT-338, will present the findings in a poster this…

The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to CT103A, an experimental CAR T-cell therapy that IASO Biotherapeutics and Innovent Biologics are developing to treat relapsed or refractory multiple myeloma. Orphan drug designation is given to therapies with a potential to substantially improve…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Arch Oncology‘s experimental immune-modulating therapy AO-176 as a potential treatment for relapsed or refractory multiple myeloma. This designation, given to therapies with the potential to improve care for conditions that affect fewer than 200,000 people…