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A Spectrum Prescription drugs drug developed to deal with a uncommon sort of lung most cancers has been rejected by the FDA, main the biotech firm to implement an instantaneous restructuring that can scale back headcount by 75%.
The regulatory choice introduced on Friday got here two months after an unbiased FDA advisory committee voted that the advantages of the drug, poziotinib, don’t outweigh its dangers. In response to Boston-based Spectrum, the FDA mentioned the corporate must generate further knowledge from one other randomized scientific trial. Slightly than doing that, Spectrum will cease work on the compound and focus as a substitute on commercializing one other product that was lately authorised for treating most cancers sufferers.
Spectrum had developed poziotinib as a remedy for sufferers whose beforehand handled non-small cell lung most cancers (NSCLC) reveals HER2 exon 20 insertion mutations. This uncommon genetic signature is present in estimated 2% to 4% if NSCLC circumstances. Poziotinib is a small molecule designed to dam signaling of the EGFR household of tyrosine-kinase receptors, enzymes that when mutated, drive most cancers progress. Whereas tyrosine kinase inhibitors can be found to deal with varied sorts of most cancers, there aren’t any FDA-approved therapies for metastatic NSCLC characterised by HER2 exon 20 insertion mutations.
In the course of the September advisory committee assembly, FDA workers flagged security issues about Spectrum’s drug that included the report of grade 3 or 4 adversarial occasions in 85% of sufferers. FDA briefing paperwork additionally famous that the corporate was searching for accelerated approval on the once-daily 16 mg dose however the deliberate confirmatory research would check an 8 mg dose twice each day.
In a ready assertion, Spectrum President and CEO Tom Riga mentioned that following the damaging advisory committee vote, the corporate was not stunned by the FDA choice. He added that although Spectrum believes the drug may provide a “significant remedy possibility for sufferers,” the corporate has determined to deprioritize this system. The corporate will discover strategic alternate options for poziotinib, together with probably partnering with different corporations on additional improvement of the molecule. However within the meantime, stopping work on this system means a company restructuring that can save sufficient money meant to maintain the corporate going by way of 2024. In its third quarter 2022 monetary report, Spectrum reported its money place was $56.2 million.
As of the top of final yr, Spectrum employed 163 full-time staff, in line with the corporate’s 2021 annual report. The employees who stay after the restructuring will deal with eflapegrastim, a drug developed to deal with a typical most cancers remedy complication known as febrile neutropenia. This situation is characterised by dangerously low ranges of neutrophils, a kind of white blood cell. Sufferers who develop this complication are vulnerable to infections. Customary remedy is granulocyte-colony stimulating issue (G-CSF), which incorporates the bone marrow stimulant filgrastim and pegfilgrastim, a long-lasting type of filgrastim.
Spectrum’s eflapegrastim, authorised in September, is a long-acting G-CSF drug in a novel formulation. The corporate is advertising the drug underneath the identify Rolvedon. This product competes in opposition to a long-acting colony stimulating issue from Amgen known as Neulasta. Different rivals within the combine embrace biosimilars from Coherus BioSciences, Viatris, Sandoz, and Pfizer.
Photograph: Mohammed Haneefa Nizamudeen, Getty Pictures