FDA Delays Decision On Spectrum's Neutropenia Drug Due To COVID-19 Related Travel Restrictions

(RTTNews) - The FDA has decided to delay its decision on Spectrum Pharmaceuticals' (SPPI) Rolontis, which was due on October 24, as the regulatory agency has been unable to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel curbs.

It should be noted that this is not a Complete Response Letter for Rolontis.

Rolontis is proposed for the treatment of chemotherapy induced neutropenia, a common and potentially hazardous complication of chemotherapy. Amgen's Neupogen and Neulasta are popular branded drugs to treat neutropenia, for which a couple of biosimilars have also been approved.

The global neutropenia treatment market, valued at $12.6 billion in 2019, is expected to reach $19 billion by 2027, according to a report by ResearchAndMarkets.com.

Spectrum Pharma noted that it will continue to work with the FDA in order to identify a strategy for preparing the necessary inspection.

In pre-market trading Monday, SPPI is down 1.47% at $3.35.