PDUFA date for sBLA on NHL drug Zevalin is July 2.
Spectrum Pharmaceuticals will receive $9.5 million from two existing investors through a direct offering. It included some 170,000 shares at a price of $5.83 for a total of $10 million. The firm is currently preparing for its PDUFA date, scheduled for July 2, related to a label expansion for lymphoma drug Zevalin.
The drug is already approved to treat patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), including those who have rituximab-refractory follicular NHL. It is under priority review as a consolidation therapy in patients with follicular B-cell non-Hodgkin’s lymphoma who achieve a response to first-line therapy.
Zevalin is being developed and commercialized by RIT Oncology, a joint venture set up between Spectrum and Cell Therapeutics in November 26, 2008, for this particular purpose. Since then, Cell Therapeutics has completely sold its 50% stake in RIT in favor of near-term cash to help with development and regulatory activities related to pixantrone, its lead candidate for NHL. Cell Therapeutics obtained $15 million when RIT was formed and $18 million when it sold its stake.
Now approval of Zevalin rests on Spectrum’s shoulders. “The addition of Zevalin as a consolidation therapy could represent a significant advancement and a changing treatment paradigm for patients with non-hodgkin’s lymphoma,” says Rajesh C. Shrotriya, Spectrum chairman, president, and CEO. “Patients achieving a complete remission after induction chemotherapy who received Zevalin consolidation achieved a median progression-free survival benefit of greater than 67 months, compared to 30.8 months in the control arm.”