Blenrep Combination Therapy Approved by FDA for Relapsed or Refractory Multiple Myeloma

Blenrep (belantamab mafodotin-blmf) is a type of cancer medicine called an antibody-drug conjugate. It works by finding and attaching to a protein called B-cell maturation antigen (BCMA), which is found on multiple myeloma cells. Once inside the cancer cell, Blenrep releases a substance that helps destroy the cell.

The FDA has approved Blenrep to be used with two other medicines – bortezomib and dexamethasone – for adults with multiple myeloma that has come back or stopped responding to previous treatments. To qualify, you must have already tried at least two other types of treatment, including a proteasome inhibitor and an immunomodulatory medicine.

Multiple myeloma is the third most common blood cancer in the world, with about 180,000 new cases each year. It often goes through cycles of getting better and then coming back, and over time, it can become harder to treat. That’s why new treatment options are important.

What makes this approval stand out is that Blenrep is the only BCMA-targeting therapy currently available in community clinics, where most people with multiple myeloma –about 70% – get their care. This means more people may be able to access advanced treatment without needing to travel to large cancer centers.

Why Was It Approved?

Blenrep was approved based on results from a study that compared it to a standard treatment. In the study, people who received Blenrep with bortezomib and dexamethasone slowed their cancer from getting worse – about three times longer than those who got the standard treatment. More people also responded to the Blenrep combination, meaning their risk of death was reduced.

But the treatment does come with serious side effects. Eye problems were the most common. In the study, nearly all people had some kind of eye issue, and many had severe symptoms like blurry vision, dry eyes, or changes to the surface of the eye. Other side effects included low blood counts, infections such as pneumonia, and liver issues. Your doctor will determine if the dose of Blenrep needs to be adjusted if side effects occur. Many people who had vision problems saw their eyesight improve or return to normal over time after the dose was reduced or Blenrep was discontinued.

Because of the risk to your eyes, Blenrep is only available through a special safety program called REMS (Risk Evaluation and Mitigation Strategy). This program requires regular eye exams and close monitoring during treatment.

What Do I Need to Know?

Blenrep is given through an IV (into a vein) once every three weeks. For the first eight treatment cycles, it’s used with bortezomib and dexamethasone. After that, you may continue with Blenrep alone until your cancer worsens or side effects become too serious.

Because of the high risk of eye problems, you’ll need an eye exam before each dose. The REMS program helps make this process easier by improving coordination between your health care provider and your eye specialist. You’ll also be asked to use preservative-free artificial tears at least four times a day and to avoid wearing contact lenses while on treatment.

Your health care provider will also check your blood counts and liver function regularly. Blenrep can lower your platelet levels, which may raise your risk of bleeding, and it can affect your liver.

Women who can become pregnant need to use effective birth control during treatment and for four months after the last dose, since the medicine could harm an unborn baby. Men with female partners who can become pregnant need to use effective birth control during treatment and for six months after the last dose.

Blenrep is not meant to be your first treatment for multiple myeloma. But if your cancer has come back or stopped responding to other treatments, it may be an option that your doctor suggests.