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Roche's Tecentriq Wins Speedy U.S. FDA Review For Small Cell Lung Cancer

(Reuters) Dec 5, 2018 - Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues. The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone. Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.

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H. Jack West, MD (Posted: December 05, 2018)

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This will be an important development for thoracic oncology. The results of the IMpower133 trial, which demonstrated a significant survival benefit with the addition of atezolizumab to standard carbo/etoposide chemo as first line treatment for extensive stage small cell lung cancer (SCLC), were not astonishingly better than chemo, but they are enough that they should change the standard of care. Significant improvements in overall survival, even if not overwhelming, are infrequent enough in oncology in general and SCLC specifically, that we should be eager to adopt them when available. Having this regimen approved will make it far easier to pursue this combination broadly as a new standard of care.

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