FDA Grants Accelerated Approval to New Drugs for Blood Cancers

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for 2 new drugs for the treatment of blood cancers.

Blenrep (belantamab mafodotin-blmf) has been granted accelerated approval for the treatment of adults who have relapsed or refractory multiple myeloma. It is for people who have received at least 4 prior therapies including:1

  • An anti-CD38 monoclonal antibody
  • A proteasome inhibitor
  • An immunomodulatory agent

Monjuvi™ (tafasitamab-cxix) has also been granted accelerated approval. It is approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified. This includes DLCBL from from low grade lymphoma, and also those who are not eligible for autologous stem cell transplant.2

Accelerated approval is granted to new drugs that are very promising and could make a positive impact on the treatment of serious conditions. This helps drugs like Blenrep and Monjuvi become available sooner.3

Information about Blenrep

Blenrup belongs to a class of drugs called antibody-drug conjugates (ADC). They target and kill tumor cells without harming healthy cells.1

Blenrep was studied in a multicenter trial that included 218 people. The overall response rate, or percent of people whose cancer shrunk or disappeared, of people using Blenrep over 6 months or more was about 73 percent.1

There is a significant risk of ocular (eye) toxicity, so the drug is currently only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Continued approval of Blenrep may require that the makers of the drug keep studying its risks and benefits in more clinical trials.1

Common side effects on Blenrep include:1

  • Keratopathy (damage to the cornea because of dryness)
  • Decreased or blurred vision
  • Nausea
  • Fever
  • Fatigue

For more information, read the full prescribing information of Blenrep.

Information about Monjuvi

Monjuvi belongs to a class of drugs called monoclonal antibodies. They work by attaching to the targets found on specific types of cancer cells.2

Monjuvi was studied in a multicenter trial that included 81 people. The overall response rate, or percent of people whose cancer shrunk or disappeared, was 55 percent. Continued approval of Monjuvi may require that the makers of the drug keep studying its risks and benefits in more clinical trials.2

Common side effects of Monjuvi include:2

  • Low white blood cell count
  • Fatigue
  • Anemia
  • Diarrhea
  • Low platelet levels
  • Peripheral edema
  • Respiratory tract infections
  • Decreased appetite

For more information, read the full prescribing information on Monjuvi.

Things to think about

While both of these drugs were granted accelerated approval, they may not be right for everyone with these conditions. Tell your doctor about any other medications or supplements you are taking, as well as any other medical conditions you might have. Talk with your doctor about your current treatment and whether these drugs may be right for your situation.

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