Immunotherapy's Effect on the Upper GI Cancer Treatment Paradigm

The FDA approved lirafugratinib in FGFR2+ cholangiocarcinoma and belzutifan plus lenvatinib in advanced ccRCC, and more.

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FDA grants priority review to durvalumab plus enfortumab vedotin for cisplatin-ineligible MIBC based on positive phase 3 VOLGA data.

Results from an early-stage clinical trial found encouraging outcomes in newly diagnosed pancreatic cancer that had spread to distant organs.

Read a refresh of GI cancer FDA news from August 2026, including the approval of a RAS(ON) inhibitor in metastatic pancreatic cancer.

The FDA has approved lirafugratinib (Lyrfigtu) for the treatment of adult patients with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement.

Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.

The FDA granted final approval to Lutetium Lu 177 dotatate biosimilar for patients with SSTR-positive GEP-NETs.