FDA shoots down Spectrum's neutropenia drug, citing manufacturing issues
In another setback for Spectrum Pharmaceuticals, the FDA has rejected its lead drug for neutropenia in patients receiving cancer drugs.
The company said Friday the CRL from the FDA cited manufacturing deficiencies, indicating that a reinspection will be necessary of the South Korea-based Hanmi Bio Plant that makes the drug, known as Rolontis (eflapegrastim).
That manufacturing plant previously delayed the FDA’s decision on Rolontis because of Covid-related travel restrictions that prevented FDA personnel from getting to the site until May.
The company did not respond to a request for comment on whether that May inspection by the FDA resulted in a Form 483.
And while the Spectrum announcement of the CRL did not mention any safety or efficacy concerns related to Rolontis, which won approval in South Korea in March, a spokesperson clarified to Endpoints News, “As part of the response to the CRL, it will include any safety or clinical updates that need to be provided to the agency. But no additional clinical trials were requested and no clinical deficiencies were cited in the CRL.”
The company’s stock slid by more than 30% in pre-market trading.
Back in 2019, Spectrum pulled its application from FDA for Rolontis, which aims to compete with Amgen’s blockbuster Neulasta, after other manufacturing issues.