Spectrum Pharmaceuticals Inc., a biotechnology company focusing on hematology and oncology, recently completed enrollment for its Rolontis Phase 3 Advance pivotal study.
The study, conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration, will evaluate the safety and efficacy of Rolontis for chemotherapy-induced neutropenia in patients with breast cancer.
"I am pleased to report that we have been able to complete enrollment in the advance study ahead of schedule," Dr. Rajesh Shrotriya, chairman and CEO of Spectrum Pharmaceuticals, said in a statement. "We plan to announce topline data early next year and expect to file a BLA in 2018. Recover, the second Phase 3 study for Rolontis, is a smaller study that will include sites in the U.S. and Europe, and is currently enrolling patients. Recover will leverage established relationships with U.S. sites from the advance study to help expedite enrollment.”
Shrotriya said the drug can change the company’s growth timeline – its target market is a multi-billion dollar industry.
“We are excited to be in the final stages of what could be a transformational development for the company,” Shrotriya said.