FDA ruling should revive overlooked NHL therapy

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If all of the data for an anti-cancer treatment regimen says it's effective, safe, quick, with fewer side effects and fewer hassles, you would expect oncologists and patients to be falling over themselves to put it to work. That it hasn't happened yet is the mystery of Zevalin.

Zevalin (ibritumomab tiuxetan) is an anti-CD20 radiotherapeutic antibody administered as part of a therapeutic regimen against previously untreated follicular lymphoma (NHL) in patients who achieved a partial or complete response to first-line chemotherapy, and for patients with relapsed or refractory low-grade or follicular B-cell NHL.

The regimen lasts no more than 10 days. Most patients don't lose their hair. There are just three steps that make up the regimen--two infusions of rituximab followed by one infusion of Zevalin (known as RRZ)--and all of the data points to Zevalin being as effective as any other therapeutic option for this patient population--in some cases, more effective.

In November, the FDA removed Zevalin's so-called bioscan requirement. This was an added pair of steps that involved injection with an a diagnostic dose of radiolabeled indium-111 (ibritumomab tiuxetan) and a full-body scan at a nuclear imaging center within 10 minutes, something that was then repeated a few days later.

The FDA's removal of this requirement eases the logistics of coordinating a patient's treatment, although it still requires the oncologist to refer a patient to a radiation oncologist or nuclear medicine doctor because Zevalin is radiolabeled.

Although the regimen is now easier to coordinate, the key to more patients enjoying the therapeutic benefits of Zevalin is in FDA approval as a first-line therapy. It can be administered off-label, but the up front costs are beyond the affordability of most patients. In order for Zevalin to be considered a first-line therapy, clinical trials will be necessary, and those will be difficult to carry out.

Regardless, Zevalin is a rare example of a proven therapeutic option for many indolent B-cell non-Hodgkin's lymphoma patients that is overlooked or underused for no good reason beyond logistics. Patients should be better informed about all their options, whether the best regimen for them involves the prescribing doctor or not.

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