FLINT, Mich., April 22, 2014 /PRNewswire-iReach/ -- The US Food and Drug Administration has announced the expanded approval of Arzerra® (ofatumumab) in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukemia (CLL). Arzerra® was previously approved by the FDA in October 2009 for the treatment of CLL resistant to other forms of chemotherapy. Diplomat has access to dispense Arzerra®.
In the clinical trials results were evaluated based on progression free survival (PFS), which is the length of time a patient lives with a disease but it does not worsen. Arzerra® in combination with chlorambucil showed an average PFS of 22.4 months as compared to an average PFS of 13.1 months in patients receiving chlorambucil alone.
According to the American Cancer Society, CLL accounts for approximately one-third of new leukemia cases in adults. The average age at diagnosis is 72 years and is considered extremely rare in patients under the age of 40.
The most common adverse reactions to Arzerra® were related to the administration of the drug via infusion and were considered to be Grade 2 or lower. The most common adverse reactions unrelated to the infusion process were neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory infection, arthralagia and upper abdominal pain.
Arzerra® is manufactured by GLAXO GROUP LIMITED and distributed by Glaxo Smith Kline. For full prescribing information, please visit the manufacturer's website.
About Glaxo Smith Kline
Glaxo Smith Kline is a UK-based manufacturer of pharmaceuticals, biologics, vaccines and consumer healthcare products. Headquartered in Brentford, England, Glaxo Smith Kline is the fourth largest pharmaceutical company in the world.
Diplomat serves patients and physicians in all 50 states as the nation's largest independent specialty pharmacy. Headquartered in Flint, Mich., the company focuses on medication management programs for people with specialized, long-term medical needs, including cancer, HIV, Hepatitis C, multiple sclerosis and many other serious or chronic conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: "Take good care of patients, and the rest falls into place." Today, that tradition continues — always focused on increasing adherence and improving outcomes. Diplomat is accredited by URAC, PCAB, VAWD, ASHP and ACHC. Learn more at diplomat.is.
Media Contact: Gary Rice, Diplomat Pharmacy, 810-768-9863, firstname.lastname@example.org
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SOURCE Diplomat Pharmacy