Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) on November 18, 2011 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."
“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.”
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 center 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 ZEVALIN on Day 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.
"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 multicenter, 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 therapeutic 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 plans to unveil a new marketing campaign for ZEVALIN at the upcoming annual meeting of the American Society of Hematology to be held in San Diego on December 9-13, 2011. Additional new clinical data from ZEVALIN will also be presented at ASH 2011.
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