Drug Updates & News

The previous articles have outlined the clinical outcomes of clinical trials evaluating bendamustine in chronic lymphocytic leukemia (CLL) and non-Hodg­kin lymphoma (NHL). The third in the series of articles discusses the short-term toxicities of bendamustine from these clinical trials.
This is the third article in a 4-part series on bendamustine. While the previous article discussed the efficacy of bendamustine for patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) in the registration studies cited in the US product labeling, this article discusses its safety
Bendamustine is an active chemotherapy agent approved by the FDA for the treatment of patients with chronic lymphocytic leukemia (CLL) and for specific populations of patients with non-Hodgkin lymphoma (NHL).
Bendamustine is approved for single-agent use in chronic lymphocytic leukemia (CLL) based on the result from a phase 3 trial comparing bendamustine and chlorambucil.
The previous articles have outlined the clinical outcomes of clinical trials evaluating bendamustine in chronic lymphocytic leukemia (CLL) and non-Hodg­kin lymphoma (NHL). The third in the series of articles discusses the short-term toxicities of bendamustine from these clinical trials.
In 2011, the first anticytotoxic T-lymphocyte antigen (CTLA)-4 therapy ipilimumab was approved by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma based on a demonstrated overall survival benefit with this agent in phase 3 clinical trials.

The drug shortage crisis is easing, but an actual solution to the problem is still elusive, according to participants in a press briefing that addressed the issue at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois.

Richard Schilsky, MD, chair of ASCO’s government relations committee and an oncologist at the University of Chicago, indicated, “Patient care has been threatened in many cases. But the good news is that the frequency of drug shortages is beginning to decline.”

At one New York medical center, half of the cancer patients required drugs that were considered in short supply in 2010 and 2011, and 10% were forced to receive an alternative, according to a study presented at the 2012 ASCO Annual Meeting (Abstract 6114).

While the investigators hope that this did not compromise efficacy, about one-third of the time the physicians felt the substitute was inferior, said Daniel J. Becker, MD, of St. Luke’s-Roosevelt and Bet h Israel M edic al Center, New York, who led the study presented at ASCO.

The drug shortage crisis is easing, but an actual solution to the problem is still elusive, according to participants in a press briefing that addressed the issue at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois.

Richard Schilsky, MD, chair of ASCO’s government relations committee and an oncologist at the University of Chicago, indicated, “Patient care has been threatened in many cases. But the good news is that the frequency of drug shortages is beginning to decline.”

At one New York medical center, half of the cancer patients required drugs that were considered in short supply in 2010 and 2011, and 10% were forced to receive an alternative, according to a study presented at the 2012 ASCO Annual Meeting (Abstract 6114).

While the investigators hope that this did not compromise efficacy, about one-third of the time the physicians felt the substitute was inferior, said Daniel J. Becker, MD, of St. Luke’s-Roosevelt and Beth Israel Medical Center, New York, who led the study presented at ASCO.

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