Spectrum Prescribed drugs (NASDAQ:SPPI) misplaced ~14% pre-market Friday after the biotech introduced that the FDA declined to approve its New Drug Software (NDA) for tyrosine kinase inhibitor poziotinib focused at sure sufferers with non-small cell lung most cancers (“NSCLC”).
With the NDA, Spectrum (SPPI) had sought the U.S. authorization of poziotinib for sufferers with beforehand handled domestically superior or metastatic non-small cell lung most cancers with HER2 exon 20 insertion mutations in genetics.
Citing the Full Response Letter (CRL), the corporate stated it must generate extra information, together with a randomized managed examine to help poziotinib approval.
Tom Riga, the Chief Government Officer of Spectrum (SPPI), stated that following “cautious consideration, now we have made the strategic resolution to instantly de-prioritize the poziotinib program.”
“We proceed to imagine that poziotinib might current a significant therapy choice for sufferers with this uncommon type of lung most cancers, for whom different therapies have failed,” he added, noting that the corporate is weighing potential strategic options for the therapy.
With the choice to de-prioritize poziotinib, Spectrum (SPPI) stated it has began a course of to chop its R&D workers by about 75%. The corporate expects that with price financial savings from restructuring, it should have ample working capital to help strategic realignment via 2024.
The regulatory setback for poziotinib comes after an impartial group of consultants on the FDA voted in opposition to its approval in September.