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Roche announced that the European Commission has approved Tecentriq as a first-line treatment for adults with metastatic non-small cell lung cancer, or NSCLC, whose tumors have high PD-L1 expression, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. "Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, giving physicians and patients greater flexibility on how they manage their treatment," Roche said.

Atea Pharmaceuticals (AVIR) announced that the first patient has been dosed in the Phase 3 MORNINGSKY trial, a multicenter trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is anticipated to enroll approximately 1,400 non-hospitalized adults and adolescents with mild to moderate COVID-19, is currently enrolling patients at clinical trial sites outside the United States. MORNINGSKY is expected to have an extensive global footprint and will include a large number of clinical sites worldwide, including Japan. AT-527 is an orally administered, direct-acting antiviral in development and derived from Atea's purine nucleotide prodrug platform. Under a strategic collaboration, Roche (RHHBY) and Atea are jointly developing AT-527 for the treatment of COVID-19.

Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq(R) (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1-stained tumor-infiltrating immune cells covering greater than or equal to5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Today's ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.