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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…

Oncopeptides received a positive opinion from an arm of the European Medicines Agency (EMA) that is expected to take the company one step closer toward European Union approval to market Pepaxti (melphalan flufenamide, also called melflufen) in combination with dexamethasone for hard-to-treat multiple myeloma. With the Committee for Medicinal…

Note: This story was updated July 13, 2022, to correct the name of Rare-X’s CEO Charlene Son Rigby. Nonprofits, scientists, governmental organizations, and the rare disease drug development industry have long cited 7,000 as the average number of rare diseases in the world.

Talquetamab, a first-in-class antibody treatment being developed by Janssen Research & Development, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for hard-to-treat multiple myeloma. The designation was awarded based on the positive safety and efficacy findings of a Phase 1/2 clinical trial involving adults…

The China National Medical Products Administration (NMPA) has agreed to review an application for Equecabtagene autoleucel — the country’s first chimeric antigen receptor (CAR) T-cell therapy — for relapsed or refractory multiple myeloma. The CAR T-cell therapy, the first to be developed domestically in China, was awarded breakthrough…

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Nammi Therapeutics’ lead immunotherapy candidate QXL138AM for multiple myeloma. The first-in-class therapy is designed to kill targeted cancer cells without the “significant toxicities” of other treatments also based on the interferon-alpha (INF-alpha) protein, Nammi…

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…

A CAR T-cell therapy called CART-ddBCMA that targets the protein BCMA — produced at high levels in myeloma cells — safely led to lasting responses in relapsed and refractory multiple myeloma (RRMM) patients, a Phase 1 study showed. Given the small study size, further trials in larger groups…