FDA delays approval of Spectrum Pharma's drug

FDA delays approval of Spectrum Pharma's drug due to Covid-19

Representative image/Credit: Reuters Photo

The US health regulator has deferred a decision on Spectrum Pharmaceuticals' drug candidate to treat chemotherapy induced loss of white blood cells in cancer patients due to Covid-19 related travel curbs, the company said on Monday.

The US Food and Drug Administration was unable to inspect the company's South Korea-based manufacturing plant, a step required before the approval of the drug, the company said, sending its shares down 2.3% before the bell.

"We are actively working with the FDA to find a way to expedite the plant inspection," Chief Executive Officer Joe Turgeon said in a statement.

The company clarified that the move was not a Complete Response Letter (CRL) from the FDA. Receiving a CRL indicates the regulator has completed its review of a new drug application and decided not to approve it in its present form.

Spectrum is seeking approval for its drug Rolontis to treat Neutropenia, a side effect of the treatment of cancer with chemotherapy or radiation therapy.