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Multiple Myeloma

On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.
San Diego, CA—The results of a phase 2 clinical trial presented at ASH 2018 suggest that early therapeutic intervention is beneficial in patients with high-risk smoldering multiple myeloma.
In the CHAMPION-1 study, patients with relapsed or refractory multiple myeloma and 1 to 3 previous regimens who received once-weekly carfilzomib had a 77% overall response rate and a median PFS of 12.6 months.
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 30,280 new cases of multiple myeloma will be diagnosed in 2017, and 12,590 deaths will be attributed to the disease. In the past 20 years, mortality rates associated with multiple myeloma have declined. Novel therapies, as well as improvements in autologous hematopoietic stem-cell transplantation (HSCT) procedures and supportive care, have contributed to extended survival for patients with this malignancy.

An interrupted time-series analysis by David Merola, PharmD candidate, Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA, and colleagues, showed a significant increase in missed workdays per month after the initial diagnosis of multiple myeloma among patients who received oral or injectable cancer therapy.

Historically, therapies for patients with MM included high-dose dexamethasone, alkylating agents, and autologous stem cell transplantation. In the late 1990s, a new era in myeloma treatment began with the introduction of the immunomodulatory drug (IMiD) thalidomide, followed by subsequent development of the proteasome inhibitors bortezomib and carfilzomib, and the next-generation IMiDs lenalidomide and pomalidomide.

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