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PDUFA Dates Pushed for Sotorasib/Obeticholic Acid in GI Indications
PDUFA Dates Pushed for Sotorasib/Obeticholic Acid in GI Indications

October 22nd 2024

The FDA has pushed back PDUFA dates for sotorasib and obeticholic acid for metastatic CRC and primary biliary cholangitis indications.

Omitting bolus 5-fluouracil in chemotherapy-based treatment for patients with gastrointestinal cancers may reduce adverse effects and healthcare costs.
5-FU Bolus Omission May Reduce Toxicity, Maintain Efficacy in GI Cancers

October 14th 2024

Ten votes were cast against PD-L1 as an efficacy biomarker for therapies intended to treat patients with gastric or GEJ adenocarcinoma.
ODAC Votes Against PD-L1 as Efficacy Biomarker in Gastric Cancers

September 26th 2024

Retifanlimab Plus Carboplatin Meets PFS End Point in Metastatic SCAC
Retifanlimab Plus Carboplatin Meets PFS End Point in Metastatic SCAC

September 14th 2024

The use of 5-fluorouracil decreased toxicity and possible savings in first-line advanced gastrointestinal cancers.
Omission of 5-FU From Combo Therapy May Improve Results in Advanced GI Cancers

September 9th 2024

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