Spectrum Pharmaceuticals, a biotechnology company, has announced that it has received the US Food and Drug Administration (FDA) approval to remove the pre-treatment biodistribution evaluation requirement using Indium-111 Zevalin imaging dose followed by a gamma scan before administering the Zevalin therapeutic dose. This pre-treatment biodistribution evaluation requirement is more commonly referred to as the "bioscan."
Prior to the bioscan removal, treatment with Zevalin was complex. Typically, patients received an infusion of rituximab on Day 1, followed by a diagnostic dose of radiolabeled Indium-111 Zevalin and a full-body scan at a nuclear imaging centre within ten minutes and again on Day 3 or 4. Patients would then receive another infusion of rituximab and a 10-minute injection of the therapeutic dose of ZEVAL Zevalin 7, 8, or 9. With the bioscan requirement removed, patients undergoing treatment with Zevalin will receive the two infusions of rituximab followed by a 10-minute injection of Zevalin. This simplified regimen will now be called "RRZ" — rituximab, rituximab, Zevalin.
Zevalin (ibritumomab tiuxetan), injection for intravenous use is indicated for the treatment of patients with previously untreated follicular non-Hodgkin Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. Zevalin is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin lymphoma.
Zevalin is a CD20-directed radiotherapeutic antibody. The Zevalin therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled Zevalin for therapy. The Zevalin therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Zevalin builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
"We are pleased to announce that for both the patients and treating physicians Zevalin treatment just became much simpler. Non-Hodgkin lymphoma patients undergoing treatment with Zevalin no longer need to be exposed to unnecessary radiation with Indium-111 or be burdened by the inconvenience of the bioscan requirement. The need for coordination between physicians and nuclear imaging centers for the bioscan will also be eliminated," said Rajesh C. Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals.
Zevalin was first approved in February 2002 for the treatment of follicular NHL patients who had recurred or progressed after other systemic therapies. In September 2009, Zevalin was approved as part of the first-line setting based on results from a 414-patient study that showed a 54% decreased risk of progression with Zevalin. A 130-patient multi-centre, randomized, open-label clinical study comparing the efficacy of the Zevalin therapeutic regimen versus rituximab in patients with relapsed or refractory low-grade or follicular NHL showed that Zevalin erapeutic regimen produced an overall response rate of 83% compared to 55% with rituximab.
According to the SEER Cancer Statistics provided by the National Cancer Institute, on January 1, 2008, in the United States there were approximately 454,378 men and women alive who had a history of non-Hodgkin lymphoma.
"Despite Zevalin's excellent therapeutic profile, as recognized by Zevalin's inclusion in the NCCN guidelines for appropriate patients with follicular lymphoma, there has been a limited penetration of the potential market. With this approval, we believe that physicians, patients and payers will find Zevalin to be an exceedingly more attractive treatment option. Spectrum is committed to unlocking Zevalin's clinical value for patients and financial value for shareholders. Removal of the bioscan is an important step toward our fulfilling these objectives," Dr. Shrotriya added. "With another significant FDA milestone reached today, Spectrum has once again demonstrated its ability to succeed in complex regulatory filings to support the safety and efficacy of its therapies."
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in haematology and oncology.