Dive Brief:
- Spectrum Pharmaceuticals Inc. plans to file for approval of its chemotherapy side effect drug Rolontis later this year, announcing positive results from a Phase 3 study of the biologic on Feb. 5.
- Rolontis met its primary endpoint in the trial, demonstrating a comparable reduction in the duration of severe neutropenia versus Amgen Inc.'s Neulasta among early-stage breast cancer patients receiving chemotherapy. Adverse effects were similar between the two groups, Spectrum said.
- A second late-stage study of Rolontis, dubbed RECOVER, has completed enrollment in the same patient population.
Dive Insight:
Spectrum is positioning Rolontis (eflapegrastim) as an alternative to Amgen's Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor (G-CSF) used to help reduce the neutropenic effects of chemotherapy.
The positive top line data will support Spectrum's planned Biologics License Application, set to be filed in the fourth quarter of this year. RECOVER, which was initiated in April 2017, is designed to further bolster the data package behind Rolontis.
"If approved, this drug would be a welcome addition to supportive care treatment options for cancer patients receiving myelosuppressive cytotoxic chemotherapy," said Lee Schwartzberg, professor of medicine, the University of Tennessee Health Science Center.
Neulasta is one of Amgen's top-selling drugs, notching sales of $1.1 billion in the fourth quarter last year and $4.5 billion for 2017 overall.
Biosimilars threaten to bring new competition to the market, but regulatory setbacks have slowed candidates in the U.S.
Mylan NV and Biocon Ltd. filed in 2017 for approval of their biosimilar, MYL-1401H, but received a Complete Response Letter rejecting the drug last fall. Coherus BioSciences Inc.'s copy was turned down by the Food and Drug Administration in 2017 as well, while Novartis AG's Sandoz unit's candidate hit a roadblock in 2016 and has yet to be resubmitted.
In addition to competing with Neulasta, these biosimilars could also have an impact on Rolontis' potential commercial success, if it is approved.
Spectrum picked up Rolontis from Hanmi Pharmaceuticals in 2012, securing worldwide rights outside Korea, China and Japan. The company also has Qapzola (apaziquone) in Phase 3 studies for intravesical instillation in non-muscle invasive bladder cancer; and poziotinib in Phase 2 in lung and breast cancer.