On November 25, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum’s New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, NOV 25, 2022, View Source [SID1234624420]). The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.
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"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed."
Mr. Riga continued, "We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients. We are grateful to the patients, families, and clinicians who participated in the poziotinib program and to the team members who have dedicated their time and efforts."
The Company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%. Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.
The Company will focus efforts on driving growth for its recently launched commercial drug, ROLVEDON. ROLVEDON was approved by the FDA in September 2022. It is for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Spectrum launched ROLVEDON, which has an estimated market opportunity of approximately $2 billion, shortly following the FDA’s approval.