FDA Rejects Spectrum's Poziotinib, As Expected, Company To Cut R&D Workforce By 75%

Spectrum Pharmaceuticals Inc.'s (SPPI) Poziotinib, proposed for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations, has been denied FDA approval as expected.

In September, the FDA Oncologic Drugs Advisory Committee had voted 9 - 4 concluding that the benefits of Poziotinib do not outweigh risks despite "clear" unmet need.

Following the disappointing developments, the company has decided to immediately de-prioritize the Poziotinib program, and reduce its R&D workforce by approximately 75%.

Spectrum added that it will now focus efforts on driving growth for its recently launched commercial drug, ROLVEDON. Approved in September of this year, ROLVEDON is indicated for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Shares of Spectrum Pharma are down 13% in pre-market trade on Friday.

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