priority review
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January 7, 2019
Roche’s Tecentriq Wins Speedy U.S. FDA Review for Small Cell Lung Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“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.”
Go to full article published by Reuters on Dec 4, 2018.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.
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August 5, 2018
FDA Grants Priority Review to Keytruda Plus Chemotherapy for Lung Cancer Subtype Bookmark
Emma Shtivelman, PhDExcerpt from Healio:
“The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.
“The agency set a target action date of Oct. 30.”
Go to full article published by Healio on July 2, 2018.
If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.