FDA approves inotuzumab for adults with B-cell acute lymphoblastic leukemia

Dr. Ryan Mattison

A new drug has been approved for the treatment of B-cell acute lymphoblastic leukemia (ALL) in some adults.

A press release from the National Institutes of Health - National Cancer Institute announced the approval of the US Food and Drug Administration for inotuzumab ozogamicin. The drug is intended for adults with B-cell ALL whose cancer has a specific genetic alteration and who have either stopped responding to or never responded to standard chemotherapy.

Ryan Mattison, MD, associate professor (CHS), Hematology, Medical Oncology and Palliative Care, was quoted in the story. Dr. Mattison explained that the treatment goal for most patients with relapsed or refractory B-cell ALL is to respond well enough to salvage therapy to be able to receive a potentially curative bone marrow transplant, and that inotuzumab is “another option for trying to achieve remission or better disease control prior to transplant."

Inotuzumab ozogamicin is an antibody-drug conjugate consisting of an antibody that binds to a protein called CD22 that is found in abundance on the surface of most ALL cells. The antibody is linked to a chemical compound called calicheamicin that kills cancer cells by damaging their DNA.

In the phase 3 clinical trial that led to the approval of the drug (the INO-VATE ALL trial), 41 percent of patients who received inotuzumab were able to undergo a bone marrow transplant, compared with 11 percent who received standard chemotherapy. Dr. Mattison noted that for adults, the choice of inotuzumab or an immunotherapy called blinatumomab that was approved earlier in 2017 may rely on different factors.

Resources: