News

Nexpovio Triple Combo Approved as Myeloma Treatment in Europe

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)…

Tecvayli Recommended for Conditional Approval in Europe

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…

Pepaxti Combo Favored to Treat Advanced Multiple Myeloma in EU

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…

Talquetamab Named a Breakthrough Therapy for Hard-to-treat Myeloma

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…

1st CAR T-Cell Therapy in China for Myeloma Now Under Review

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…

Novel Immunotherapy QXL138AM Wins Orphan Drug Status in US

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 Shows Anticancer Activity in Preclinical Tests

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…

Ninlaro as Oral Combo Therapy Fails at Trial in Heavily Treated Patients

Adding Ninlaro (ixazomib) to cyclophosphamide and dexamethasone does not improve progression-free survival for multiple myeloma patients who relapsed after several lines of treatment, a Phase 2 trial reported. The study, “Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled…