Currently Viewing:
Newsroom
Currently Reading
Daratumumab Approval Yields the First Monoclonal Antibody, and Another Option, in Multiple Myeloma
November 16, 2015 – Surabhi Dangi-Garimella, PhD
This Week in Managed Care: November 14, 2015
November 14, 2015
Smoking Rates Declining but Disparities Evident: CDC Report
November 12, 2015 – Surabhi Dangi-Garimella, PhD
Learning From Your Daughters About Cancer Prevention
November 12, 2015 – Surabhi Dangi-Garimella, PhD
Public Has Concerning Response to Learning Adverse Drug Event Information
November 12, 2015 – Jessica Men
Oral Contraceptives Can Improve Outcomes in Ovarian Cancer
November 11, 2015 – Surabhi Dangi-Garimella, PhD
Narrow Network and Insolvent Exchange Plan Leaves Cancer Patients Scampering for Options
November 11, 2015 – Surabhi Dangi-Garimella, PhD
What We're Reading: Annual Flu Shots Can Reduce Effectiveness of Vaccine
November 11, 2015 – AJMC Staff
Association Between Off-Label Drug Use and Adverse Drug Events in Adults
November 11, 2015 – Jackie Syrop

Daratumumab Approval Yields the First Monoclonal Antibody, and Another Option, in Multiple Myeloma

Surabhi Dangi-Garimella, PhD
The drug was approved based on results of 2 open-label studies that showed reduction in tumor burden of patients who had previously received multiple lines of therapy.
The FDA today approved daratumumab for patients with multiple myeloma who have previously been treated with at least 3 regimens. Daratumumab, which received breakthrough status 2 years back, is the first monoclonal antibody approved for multiple myeloma.

The approval follows review of 2 open-label studies that included 106 and 42 participants. The first study (phase 2 MMY2002) saw 29% of patients with a complete or partial reduction in tumor burden that was sustained for at least 7.4 months. These patients had received a median of 5 lines of prior therapy. The second study (phase 1/2 GEN501) saw a complete or partial reduction in tumor burden of 36% of patients. These patients had received a median of 4 lines of prior therapy. Today’s approval is the first for a CD38 antibody and comes just 2 months after the drug was submitted for priority review.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, hailed daratumumab as another option for patients to turn to when their disease has developed resistance to all other existing therapies.

Some of the side-effects associated with the drug include infusion-related reactions, fatigue, nausea, back pain, fever, and cough. Daratumumab may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia), and low levels of blood platelets (thrombocytopenia).

Daratumumab, approved under the FDA’s accelerated approval program, had an orphan drug designation.

 
Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up