Spectrum Cuts NSCLC Program and 75% of Staff on Heels of CRL

FDA_Sarah Silbiger/Getty Images

Courtesy of Sarah Silbiger/Getty Images

Spectrum Pharmaceuticals made the call Friday to slash three-fourths of its workforce on the heels of a Complete Response Letter from the FDA.

The CRL followed Spectrum's NDA for poziotinib, a monotherapy oral tyrosine kinase inhibitor intended to treat patients with NSCLC with HER2 exon 20 insertion mutations.

The CRL is not surprising, as it follows a 9-to-4 thumbs down from the FDA's Oncologic Drugs Advisory Committee meeting back in September. While the FDA can choose to overrule these recommendations, the ultimate decision usually falls in line with the Committee.

The FDA will not approve the therapeutic in its present form. The ODAC cited concerns over the low overall response rate (28%), poor safety profile at the proposed once-daily 16 mg dosing and inadequate dosage optimization. More data from confirmatory trials would be required to be considered for approval, the regulator noted.

The poziotinib program will be immediately cut, with the potential for a partner to pick it up in the future. Hanmi Pharmaceutical, who originally licensed the drug to Spectrum, retains rights in Korea and China and is continuing to develop the candidate in multiple solid tumor targets.

Additionally, the Nevada-based company is trimming its R&D staff and focusing on its newly approved and first commercially launched drug, Rolvedon. Cutting 75% of its 164-head workforce is expected to save enough cash to get the company through 2024.

Rolvedon was approved in September for chemotherapy patients on myelosuppressive agents experiencing infections due to a lower-than-normal number of neutrophils in the blood. For now, it will stand alone in Spectrum's pipeline.

Spectrum isn’t the only biopharma facing the sting of layoffs. BioSpace’s Layoff Tracker shows over 45 layoff announcements in the life sciences industry since July.

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