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U.S. FDA declines to approve Spectrum“s lung cancer drug

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2022-11-25T13:14:31Z

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Spectrum Pharmaceuticals Inc (SPPI.O) said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.

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The company said it will no longer focus on developing the drug, poziotinib, for treating non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2%-4% of the cancer patients. It will instead explore strategic alternatives for it, such as partnerships with other drugmakers.

Spectrum’s shares fell 13.9% to 37 cents in premarket trading. They have fallen 42.5% since an expert panel to the FDA recommended against the drug’s approval in September.

The panel of independent experts had raised concerns over the efficacy of the treatment compared to drugs for NSCLC without mutation such as Daiichi Sankyo (4568.T) and AstraZeneca’s (AZN.L) Enhertu.

Nevada-based Spectrum said it will cut 75% of its research and development workforce and focus on its other cancer drug, Rolvedon. It had 164 employees as of Dec. 31, 2021.

Spectrum is working to shore up capital, through cost cuts, to support a wider launch for Rolvedon, which treats patients with chemotherapy-induced infections caused due to low levels of infection-fighting cells in the body.


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