25 November 2022 - - US-based biopharmaceutical company Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) has received a Complete Response Letter from the US Food and Drug Administration regarding Spectrum's New Drug Application 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 company said.

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 USD 2bn, shortly following the FDA's approval.

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 pipeline with novel assets that serve areas of unmet need.