GlaxoSmithKline has announced the accelerated approval of nelarabine (Arranon®) Injection by the FDA. This chemotherapy agent is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed following treatment with, at least two chemotherapy regimens.
This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefits have not been conducted. Postmarketing evaluation will be pursued though a randomized, multi-center, phase 3 trial.
In December 2003, nelarabine received a “fast track” designation and was later granted orphan drug status. In September 2005, the FDA’s advisory committee voted to recommend that the FDA grant accelerated approval of nelarabine for both children and adults.
The FDA has granted accelerated approval for dasatinib (Sprycel, Bristol-Myers Squibb), a new oral treatment for patients with chronic myeloid leukemia (CML). CML is a rare cancer that is characterized by the uncontrolled growth of white blood cells. CML affects about 4,600 people annually in the U.S.
The FDA has also given regular approval to this drug for use in the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), a more serious form of leukemia. Both approvals are for patients who have experienced resistance or intolerance to prior therapy.
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Dasatinib is indicated for patients with CML who are no longer responding to, or who can no longer tolerate, therapy with imatinib mesylate (Gleevec, Novartis), which was approved in 2001. It works by reducing the activity of one or more proteins responsible for the uncontrolled growth of the leukemia cells.
Dasatinib is considered an orphan drug for these indications. Its approval was based on evidence from four single-arm studies in more than 400 patients.
In a trial sponsored by the National Cancer Institute, adults with previously untreated acute promyelocytic leukemia (APL) who had standard chemotherapy (Trisenox, Cephalon) to induce remission and who then received arsenic trioxide to maintain remission had better event-free and overall survival times than patients who received only standard chemotherapy. Acute promyelocytic leukemia, an uncommon subtype of acute myeloid leukemia (AML), accounts for about 10% of AML cases. It occurs most often in young and middle-aged …
Bedford Laboratories has announced the FDA’s approval to begin shipping Pentostatin for Injection. This product is AP-rated and is equivalent to Nipent by Hospira, Inc. Pentostatin is indicated for the treatment of hairy cell leukemia.
The company will supply the latex-free injection as a sterile lyophilized powder in a single-dose vial containing 10 mg of pentostatin. Prescribing information is available upon request from the company.
(Source: Beford Laboratories, August 13, 2007
Obesity may be contributing to chemotherapy resistance and increasing relapse rates among children with leukemia. Obesity is associated with anncreased incidence of many types of cancer drugs . Given the increasing prevalence of obesity worldwide, these findings could have important implications for cancer treatment and may help to explain the increased leukemia relapse rate in obese patients.
Rasburicase (Elitek, Sanofi-Aventis U.S.) has been approved for the initial management of plasma uric acid levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy that is expected to cause tumor lysis syndrome (TLS) and elevations of plasma uric acid.