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Spectrum Sees Potential Path For Poziotinib In NSCLC Despite Expected CRL

 
• By Alaric DeArment

The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.

The FDA sent a complete response letter to Spectrum for poziotinib in NSCLC • Source: Shutterstock

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...

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