Benzinga -
- The FDA has granted a Complete Response Letter (CRL) to Spectrum Pharmaceuticals Inc's (NASDAQ: SPPI) marketing application seeking approval for poziotinib for previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations.
- The FDA issued a CRL indicating that the poziotinib application cannot be approved in its present form.
- Based on the CRL, the company would have to generate additional data, including a randomized controlled study, before approval.
- "While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President & CEO.
- Related: Despite Regulatory Setback, Spectrum Still "Unique Investment Opportunity," Says Analyst.
- The company will de-prioritize poziotinib program activities, effective immediately, and is reducing its R&D workforce by approximately 75%.
- Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.
- Spectrum will focus on driving growth for its recently launched commercial drug, Rolvedon (eflapegrastim-xnst) injection, to decrease the incidence of infection, as manifested by febrile neutropenia.
- Rolvedon is estimated to have a market opportunity of approximately $2 billion.
- Price Action: SPPI shares are down 5.93% at $0.4042 on the last check Friday.