USFDA declines to approve Spectrum Pharmaceuticals’ lung cancer drug | The Financial Express

USFDA declines to approve Spectrum Pharmaceuticals’ lung cancer drug

Poziotinib is a drug developed by Hanmi Pharmaceutical, Luye Pharma, and Spectrum Pharmaceuticals for various cancers.

USFDA declines to approve Spectrum Pharmaceuticals’ lung cancer drug
The health regulator's decision is in line with an advisory panel's recommendation to not approve the drug. (File)

Spectrum Pharmaceuticals Inc on Friday said that the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug, citing the need for an additional study.

The company now plans to de-prioritise the development of the drug, called poziotinib and said it was in the process of cutting 75 percent of its research and development workforce.

Poziotinib is a drug developed by Hanmi Pharmaceutical, Luye Pharma, and Spectrum Pharmaceuticals for various cancers.

In February this year, the FDA has accepted for review a new drug application (NDA) for poziotinib in patients with previously treated locally advanced or metastatic non–small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations.

Spectrum had 164 employees as of Dec 31, 2021.

The health regulator’s decision is in line with an advisory panel’s recommendation to not approve the drug.

(With inputs from Reuters)

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First published on: 25-11-2022 at 18:30 IST