FDA Approves TAS-102, New Nivolumab Breakthrough Designation, Two Priority Reviews, and More

Read a refresh of GI cancer FDA news from July 2026, including an NDA acceptance for a RAS(ON) inhibitor in pancreatic cancer.

In case you missed any, read a recap of the episodes of OncLive On Air that aired in July 2026.

Paul E. Oberstein, MD, discusses data for an autogene cevumeran–based regimen in pancreatic ductal adenocarcinoma.

The FDA has issued a CRL to the NDA seeking the approval of the investigational agent 177Lu-edotreotide for the treatment of patients with GEP-NETs.

The FDA approved RP1 plus nivolumab in advanced melanoma, granted olomorasib breakthrough status in KRAS G12C+ pancreatic cancer, and more.

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Early nivolumab responders sustained years-long treatment-free survival after treatment discontinuation.

Durable outcomes were reported standard-dose tivozanib monotherapy in second- and third-line metastatic RCC.