FDA issues CRL for poziotinib in non-small cell lung cancer and company announces drug 'deprioritisation'.- Spectrum Pharma
Spectrum Pharmaceuticals announced that the Company has received a Complete Response Letter (CRL) from the 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 harboring HER2 exon 20 insertion mutations.
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.
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.
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