HENDERSON, Nev. – Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations. Spectrum plans to submit a new drug application (NDA) for poziotinib later this year.
“There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted Fast Track designation for poziotinib,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “Momentum is building to unlock the potential of poziotinib.”
“We are actively preparing the NDA and delighted with this Fast Track designation,” stated Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “In addition, last week we presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 that twice daily dosing (BID) suggests improved anti-tumor activity and reduced toxicity relative to once daily dosing. We are optimistic about this BID strategy and we will provide a data update at AACR in April.”
About Fast Track Designation
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs, with the intention of getting important new drugs to patients earlier. Specifically, Fast Track designation facilitates meetings with the FDA to discuss aspects of development to support licensure and provides the opportunity to submit sections of a NDA on a rolling basis as data become available. When Fast Track designation is requested later in development, available clinical data should demonstrate the potential to address an unmet medical need. Additionally, another potential benefit of Fast Track designation is priority review, which reduces the standard 10 months NDA review to six months.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals, and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit www.sppirx.com.