publication date: Nov. 20, 2015

Approvals Granted to Darzalex and Ninlaro in Multiple Myeloma 

 

FDA granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”

Darzalex, marketed by Janssen Biotech, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells. The safety and efficacy of Darzalex were demonstrated in two open-label studies.

In one study of 106 participants receiving Darzalex, 29 percent of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the second study of 42 participants receiving Darzalex, 36 percent had a complete or partial reduction in their tumor burden.

The most common side effects of Darzalex were infusion-related reactions, fatigue, nausea, back pain, fever and cough. Darzalex may also result in lymphopenia, neutropenia, leukopenia or anemia and low levels of blood platelets.

The FDA granted breakthrough designation for this application based on preliminary clinical evidence suggesting that if approved, Darzalex may offer a substantial improvement over available therapies. Darzalex also received priority review and orphan drug designations.

Continue reading 41-43 Approvals Granted to Darzalex and Ninlaro in Multiple Myeloma

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