FDA Approves New Lymphoma Treatment

FDA approves new lymphoma treatment
This page was originally published January 9, 2018 and updated July 10, 2024.

The Food and Drug Administration (FDA) recently approved a promising new drug treatment, brentuximab vedotin, for either of two types of non-Hodgkin lymphoma. The drug’s market name will be Adcetris.

The FDA granted approval for the drug to be used in the clinical treatment of either primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides, both of which are extremely rare cutaneous T-cell lymphomas (CTCLs) that begin as rashes on the skin.

Brentuximab acts as a targeted therapy known medically as an antibody-drug conjugate. While that concept sounds quite complicated, the drug’s operative mechanism is actually quite easy to understand in practice.

The antibody binds to CD30, found on the exterior of cancer cells, and then releases the drug which kills the attached cancer cell. Brentuximab previously saw use in treatment for patients with Hodgkin lymphoma and some patients diagnosed with ALCL.

Recent trials of the new drug proved successful, prompting the FDA to approve its expanded treatment usage.

The third phase of the clinical research funded by Millennium Pharmaceuticals and Seattle Genetics involved 131 patients with some being given the new drug and others being treated with either methotrexate or bexarotene at the doctor’s discretion.

While there are other treatment options for these diseases, such as methotrexate, bexarotene, drugs known as histone deacetylase (HDAC) inhibitors, and multidrug chemotherapy regimens, these do not provide “reliable and durable” responses according to the study.

Brentuximab showed markedly better results in median progression-free survival (PFS) numbers, 17 months versus the physician’s choice group average of four.

Christopher Melani, M.D., of the Lymphoid Malignancies Branch in NCI’s Center for Cancer Research said: “These improvements—especially, the substantially longer PFS—with brentuximab vedotin compared with the physician’s choice, are important…These are impressive findings, and physicians should strongly consider this drug when treating patients with CD30-positive disease.”

The brentuximab patient group also had a greater reduction in symptoms when compared to the doctor’s choice group but brentuximab is not without its side effects. Some patients experienced peripheral neuropathy and discontinued drug use because of these symptoms with other side effects being nausea, diarrhea, and fatigue.

The results of this clinical research study move the examination of the drug brentuximab into a new phase of exploration. Doctors will now begin to look at the drug for use in other cancer treatment and in combinations with other known, effective treatment options. This will take time, however, to confirm whether or not the drug will be more effective in terms of complete response rate and progression-free survival.

“Combining this agent with other effective therapies, such as skin-directed therapy [including topical steroids and retinoids], HDAC inhibitors, and/or standard chemotherapy, will likely be tested to see if we can improve on the complete response rate and PFS and provide more durable remissions for patients,” Dr. Melani said.

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  1. It’s remarkable to see how hard people are working to find a sustainable cure for cancer. Have the side-effects of this new drug been researched yet?

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