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Cephalon’s Treanda (bendamustine) will initially see limited uptake in the first-line setting for chronic lymphocytic leukemia (CLL), if approved, physicians interviewed by Pharmawire said.

In a number of interviews, the physicians said that more data is needed to demonstrate superiority over currently used first-line treatments for the drug to garner widespread use.

Treanda is a novel chemotherapeutic agent, currently under FDA priority review with a PDUFA date of 20 March to treat CLL.

Although Treanda showed superior efficacy compared to Leukeran in a phase III study recently presented at the 2007 American Society of Hematology, physicians agreed that more data is needed to determine if the drug is as efficacious as currently used first-line treatments such as Fludara and the FCR (fludarabine, cyclophosphamide, and rituximab) regimen.

Dr John Hainsworth, director of clinical research at the Sarah Cannon Cancer Center in Nashville said that although Treanda is a drug that oncologists are comfortable using, some questions remain unanswered about its use and administration. ”Although Treanda will find use in CLL, more data is needed,” he added.

Charles Morris, VP of Clinical Research Oncology at Cephalon, said that as of now, the company does not plan on conducting any head-to-head studies with first-line treatments for CLL.

However, Cephalon is currently testing Treanda in combination with Rituxan, which appears to be an effective combination for non-Hodgkin’s lymphoma. The company will want to see more data before the initiation of other potential combination studies, said Morris.

Morris would not provide comment on whether the lack of comparison studies against current treatments such as fludarabine and FCR would limit or slow initial uptake of the drug in the first-line setting.

No matter what drug patients receive for first line treatment, Hainsworth said that nearly all patients relapse. In his opinion, Treanda will be used in the second or third-line setting, based on how long the remission period is. ”It will find use in CLL because there aren’t a lot of options in treatment,” he added.

“I don’t know if people are ready to jump on it [Treanda] immediately,” said Dr Chadi Nabhan, a physician with oncology specialists in Park Ridge, Illinois. Eventually, the drug will gain traction, Nabhan said, and he mentioned that the drug will first be widely prescribed among elderly patients.

Many elderly patients are unable to withstand the side effects of the FCR regimen, Dr Stephanie Gregory, director of the hematology section at Rush University Medical Center concurred. Despite its side effects, the FCR regimen has an excellent response rate.

When asked whether elderly patients will be able to tolerate the toxicity profile of the drug, Morris replied that the median age of patients in the study was 72, and CLL is predominately a disease of the elderly. “Based on these data, we believe our results are reflective of the patient population,” he said.

A characteristic of Treanda that is appealing to physicians is that the drug has multiple characteristics of the FCR cocktail, Gregory explained. Not only is Treanda an alkylating agent, but it also has some characteristics of a purine analog.

“This would be very exciting if you could replace that [FCR] regimen with one drug,” said Gregory.

Hainsworth, who has personal experience using Treanda, is going to be conducting a trial in patients with lymphoma. He said Treanda is a relatively well tolerated drug in the lymphoma setting.

The company also expects an October decision on a new drug application (NDA) for Treanda in relapsed indolent non-Hodgkin’s lymphoma.

Cephalon has a current market cap of USD 4.14bn.

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