SPPI - Spectrum plunges 28% after FDA scientists question poziotinib evidence for NSCLC

• US FDA scientists are concerned about the data Spectrum Pharmaceuticals ( NASDAQ: SPPI ) has provided to support its drug poziotinib for non-small cell lung cancer ahead of an advisory committee meeting on Thursday .
• Shares are down 28% in Tuesday morning trading.
• In a briefing document , the FDA scientists state the data provided shows a low overall response rate (ORR) with minimal duration of response ( DOR ). ORR was 28% while median DOR was 5.1 months.
• In addition, they say the safety profile is poor in that at the proposed dosage, 57% of patients experienced dose reductions and 85% of patients had grade 3-4 adverse events.
• Also, the FDA team faults Spectrum ( SPPI ) for what it calls inadequate dosage optimization since the company has proposed two different doses for accelerated approval and the planned confirmatory trial. "Confirmation of benefit will be significantly delayed given that confirmatory trial has not begun enrolling patients."
• Poziotinib is an oral tyrosine kinase inhibitor that inhibits the activity of epidermal growth factor receptor (EGFR [HER1], HER2, and HER4) kinases.
• Seeking Alpha's Quant Rating views Spectrum ( SPPI ) as a hold.

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