Spectrum Sees Potential Path For Poziotinib In NSCLC Despite Expected CRL

The US Food and Drug Administration handing a complete response letter (CRL) to Spectrum Pharmaceuticals Inc. for poziotinib in previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations came as little surprise. But despite the company deprioritizing the program and laying off most of its R&D workforce, it still sees poziotinib as having a potential future, perhaps by partnering or selling it to a company that could take it forward.

Spectrum announced its receipt of the CRL on 25 November, adding that based on the letter, the company would have to generate additional data, including a randomized, controlled trial, to warrant poziotinib’s approval