for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up
Top News

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

(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.

“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 regulator had warned in April it may not be able to sustain its current level of timely reviews and approvals of marketing applications as many of its staff were allocated to the coronavirus crisis.

Spectrum said 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.

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

H.C. Wainwright analyst Edward White said the drug launch is likely to be delayed by six months. “(but) the inspection will not take too long and continue to believe the data is strong and the drug will be approved,” he said.

Earlier this month, the FDA declined to approve Zosano Pharma Corp's ZSAN.O experimental migraine treatment, citing issues with its delivery during clinical trials and also sought an inspection of its manufacturing sites.

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

for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up