Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.
The U.S. Food and Drug Administration (FDA) approved a combination of Imbruvica (ibrutinib) plus rituximab (Roche’s Rituxan) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), which is a rare and incurable type of non-Hodgkin’s lymphoma (NHL). Imbruvica, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, was first approved as a single agent therapy for WM in January 2015, the company said. The approval for the combination treatment represents the “first and only chemotherapy-free combination treatment” specifically indicated for the disease, AbbVie said this morning. The latest approval also marks the ninth indication Imbruvica has been approved for in the past five years, the company added.
Thorsten Graef, AbbVie’s head of clinical development at its subsidiary company Pharmacyclics LLC, said the latest approval provides “an additional efficacious treatment option for people living with Waldenström’s macroglobulinemia.”
Waldenström’s macroglobulinemia (WM) typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected. In the U.S., there are approximately 2,800 new cases of WM each year, AbbVie noted.
“We are proud of our robust clinical development program, and this new approval reflects our continuous commitment to exploring the full potential of Imbruvica’s mechanism of action for treating patients with diseases that have great unmet medical need,” Graef said in a statement.
The FDA approved the combination treatment based off Phase III results that evaluated the combination of Imbruvica and Rituxan versus Rituxan alone in 150 patients with previously untreated and relapsed/refractory WM. At 26.5 months, the study demonstrated a significant improvement in progression-free survival (PFS) in patients who took the combination treatment versus Rituxan alone. At 30 months, PFS rates were 82 percent versus 28 percent, respectively, AbbVie reported. Additionally, Patients who took the Imbruvica/Rituxan combination also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab, the company noted.
Steven Treon, director of the Bing Center for Waldenström’s Macroglobulinemia at the Dana-Farber Cancer Institute, said Imbruvica has significantly advanced the treatment of patients with WM. The FDA’s approval of the combination treatment has added a new option for many WM patients, he said. Treon was the lead investigator of the Phase II trial that served as the basis for Imbruvica’s 2015 approval for WM.