FDA issues CRL on Spectrum's Rolontis filing

9 August 2021

Shares of Spectrum Pharmaceuticals (NasdaqGS: SPPI) fell nearly 30% on Friday, after the US oncology specialist revealed yet another delay in the approval process for its lead product candidate Rolontis (eflapegrastim).

Spectrum said that it has now received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for Rolontis.

The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary of its plant in South Korea. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.

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