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FDA delays decision on Spectrum Pharma's drug candidate due to travel curbs

The U.S. 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.

Adds details on drug, CEO comment, share movement

Oct 26 (Reuters) - The U.S. health regulator has deferred a decision on Spectrum Pharmaceuticals' SPPI.O 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 U.S. 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.

(Reporting By Mrinalika Roy in Bengaluru; Editing by Shailesh Kuber and Arun Koyyur)

((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 806749 8325;))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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