So what exactly is Abecma? The National Cancer Institute (NCI) explains that Abecma is made using a type of immune cell called T-cells. After this happens:

A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory, and [CAR T cells are] given to the patient by infusion. Abecma binds to a protein called BCMA, which is found on myeloma cells and some types of immune cells, [which] helps the body’s immune system kill cancer cells.

This most recent conditional marketing approval hinged on data from the KarMMa clinical trial. During the trial, 128 patients enrolled. After treatment, 33% of patients achieved a complete treatment response, with a 73% overall response rate considering the full scope of the trial.

In Europe, conditional marketing authorization is granted when:

• The benefits of the medicine outweigh the potential risks, despite a lower amount of clinical data being available
• Treatments may prevent, diagnosis, or treat serious, rare, or life-threatening illnesses
• A drug is needed during a pandemic or other public health crisis

Learn more about conditional marketing authorization in Europe here.

Multiple Myeloma (MM)

Multiple myeloma is a rare cancer which develops in plasma cells, a type of white blood cell usually used in immune response. Normally, plasma cells create antibodies to fight infections. However, in patients with multiple myeloma, abnormal antibodies called M proteins form in the bone marrow and crowd out healthy cells. While doctors do not know the full cause of multiple myeloma, some believe that a fully or partially missing chromosome 13 could play a role. Symptoms associated with multiple myeloma include: