Tips to remember: Treanda
- Treanda is given as a 100 mg/m2 intravenous infusion over 30 minutes on days 1 and 2 of a 28-day cycle, up to six cycles.
- Allopurinol should be considered as a preventative for patients at high risk of tumor lysis syndrome for the first few weeks
of treatment.
- Treanda for injection is available in single-use vials containing 100 mg bendamustine HCl as a white to off-white lyophilized
powder.
- CYP1A2 inducers or inhibitors have the potential to affect the exposure of Treanda.
- Treanda should not be used in patients with a known hypersensitivity to bendamustine or mannitol.
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As the first drug approved for chronic lymphocytic leukemia (CLL) since 2001, Cephalon's bendamustine (Treanda) has the potential
for significant market penetration, according to experts. The new therapy was approved by the Food & Drug Administration following
priority review in March of this year. Its broad indication does not specify whether the drug should be used as a monotherapy
or as a combination treatment, an ambiguity that could help make reimbursement easier, say the analysts.
"Bendamustine is an alkylating agent that is active against quiescent and dividing cells," said Sachin Shah, Pharm.D., BCOP,
associate professor of pharmacy practice at the Texas Tech University Health Sciences Center School of Pharmacy. "Its exact
mechanism is not well understood." However, the drug and "its derivatives form bonds with electron-rich nucleophilic moieties,
which leads to cell death via several pathways. Bendamustine is a bifunctional derivative of one of the older agents, mechlorethamine,"
he added. 
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The approval was based on analysis of 301 treatment-naïve patients with CLL. Bendamustine-treated patients had a significantly
higher rate of response (59% vs. 26%; p<0.0001) and a higher complete response rate (8% vs. <1%) than comparator drug chlorambucil
(Leukeran, GlaxoSmithKline). In addition, bendamustine patients had a significantly longer progression-free survival (18 months
vs. six months; p<0.0001) and a longer duration of response (19 months vs. seven months) than chlorambucil-treated patients.
The product's label states, however, that bendamustine's efficacy relative to first-line therapies other than chlorambucil
has not been established.
Shah reminds pharmacists that CLL is not a curable condition and primarily patients are treated based on worsening symptoms.
Although bendamustine has shown a superior response rate and progression-free survival versus chlorambucil, its efficacy versus
more efficacious fludarabine-containing regimens, such as FCR (fludarabine, cyclophosphamide, rituximab) and FR (fludarabine
and rituximab), remains to be evaluated. "At this point, bendamustine should be an option in the setting where the patient
may have been a good candidate for chlorambucil. Many times chlorambucil is considered for elderly patients," Shah explained.
And, although manageable, a patient's risk for myelosuppression and emesis should be considered in this treatment decision,
he added, since bendamustine did show a higher incidence of the two toxicities during clinical trials.
Bendamustine, which has been granted orphan drug status, should be given as a 100 mg/m2 intravenous infusion over 30 minutes
on days one and two of a 28-day cycle, for up to six cycles. Patients should be monitored for myelosuppression during therapy,
which may warrant treatment delay or dose reduction. If therapy is discontinued, patients should be monitored closely and
treatment restarted based on absolute neutrophil count (ANC) and platelet count recovery. Patients should also be monitored
for fever and other signs of infection and treated promptly.
According to Cephalon, a second application for bendamustine was filed with the FDA in December 2007 for treatment of patients
with indolent B-cell non-Hodgkin's lymphoma—an indication, if approved, that could greatly expand the market for the drug.
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