FDA Delays Review of Spectrum’s Investigational Neutropenia Drug

The FDA has had to push back its review of Spectrum Pharmaceuticals’ biologics license application (BLA) for Rolontis (eflapegrastim) due to COVID-19 travel restrictions.

The Henderson, Nev.-based drugmaker announced Monday that the agency has deferred action on Rolontis, an investigational granulocyte colony-stimulating factor drug, because it is unable to conduct a required inspection of Hanmi Bioplant, a South Korean biologics facility involved in the manufacturing process.

Spectrum is hoping to get the investigational drug approved for the treatment of neutropenia — low white blood cell counts — in patients taking anti-cancer drugs that cause reduced bone marrow activity. The agency accepted the BLA for review in December 2019 and set a decision date of Oct. 24.

Though the specific restrictions encountered by the agency are not known, South Korea has been widely praised for its effective response to the pandemic and its low number of COVID-19-related deaths.

“We are actively working with the FDA to find a way to expedite the plant inspection,” said Spectrum President and CEO Joe Turgeon. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible. The company will continue to work actively with the FDA to define an approach for scheduling the required inspection.”

The BLA is supported by phase 3 trial data that show the drug is noninferior in duration of severe neutropenia to Neulasta (pegfilgrastim) and has a similar safety profile.

Amgen earned $665 million from sales of Neulasta in 2019, but revenue was down 28 percent for the year because of competition from biosimilars.

No timeline was given for when the FDA is expected to complete its review of Spectrum’s BLA for Rolontis. — James Miessler