Spectrum Pharmaceuticals is ending the year as it started it—with a round of layoffs. Friday’s announcement of a 75% reduction in its R&D workforce has been prompted by a complete response letter from the FDA that provided the final nail in the coffin for the biotech’s ambitions for its lung cancer candidate Pozenveo.
The writing was already on the wall for the oral tyrosine kinase inhibitor, also called poziotinib, in September when the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 that Pozenveo’s benefits don’t outweigh its risks when it comes to treating locally advanced or metastatic non-small cell lung cancer in patients harboring the human epidermal growth factor receptor exon 20 insertion mutation. The FDA’s thinking was made clear in a document released ahead of the committee’s meeting, which cited concerns regarding dosing and efficacy.
In its CRL, the FDA has now confirmed that the Pozenveo application can’t be approved in its present form, according to Spectrum. It means the biotech would have to generate additional data including a randomized controlled study prior to approval.
“While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed,” Spectrum CEO Tom Riga said in a release sneaked out on the morning after Thanksgiving. “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.”
“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,” Riga added.
De-prioritizing Pozenveo as well as shrinking the R&D-related workforce by three quarters should give the company a cash runway through to 2024. The money will go toward driving growth for Rolvedon, which was approved by the FDA in September for certain adults with non-myeloid malignancies. The company said it’s eyeing an estimated $2 billion market opportunity for the drug, which may offer some comfort for executives even as they further slash the company’s ability to develop its own pipeline.
Friday’s news was only the latest setback at Spectrum, which started the year laying off 30% of the company and deprioritizing its early-stage pipeline in the wake of an FDA rejection for its neutropenia candidate Rolontis due to manufacturing shortfalls.
Even before the Rolontis saga, Spectrum had been gearing up for change. In 2019, the company sold its portfolio of seven marketed products to Acrotech Biopharma, a wholly owned subsidiary of India’s Aurobindo Pharma, for up to $300 million. That move was designed to allow the biotech to focus on its cancer prospects.