Roche's PD-L1 franchise player nabs priority review; One of world's first psychedelics research institutes opens in Australia
The FDA has just put Genentech’s latest shot at adding blockbuster sales for Tecentriq on the regulator’s inside track.
Roche said Tuesday that the agency has provided priority review status for a supplemental NDA to get the big PD-L1 franchise player approved for adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer.
Genentech researchers came up with the first evidence of disease-free survival for the drug following surgery and platinum-based chemotherapy. The drug reduced the risk of disease recurrence or death by 34%, making it a likely winner even before the Dec. 1 PDUFA date.
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