Gastrointestinal Cancer

The approval was based on efficacy and safety data from a randomized, 3-arm, open-label phase 3 CHECKMATE-8HW trial.

The antibody-drug conjugate is currently undergoing evaluation in a phase 1 trial that enrolled patients with pancreatic cancer and squamous non-small cell lung cancer (NSCLC).

Patients achieved statistically significant benefits in progression-free survival and overall response rates.

The combination was approved for treatment of patients with gastroesophageal junction (GEJ) adenocarcinoma.

The decision is based on clinically meaningful results from a phase 3 trial.

The test offers an accurate, fast, low-cost, and noninvasive tool for early diagnosis of pancreatic ductal adenocarcinoma.

Lu-edotreotide (ITM-11; ITM) met its primary endpoint of prolonging progression-free survival (PFS).

The trial meets one of the study’s dual primary endpoints of progression-free survival, but did not meet its other primary endpoint of overall survival.

Boosting ursodeoxycholic acid (UDCA) levels through dietary supplementation was shown to control tumor growth in mice with liver cancer.

The designation follows positive phase 2a trial results (NCT05104853) presented at the 2024 AASLD The Liver Meeting.

Tislelizumab is approved in combination with platinum and fluoropyrimidine-based chemotherapy as first-line treatment of unresectable or metastatic HER2-negative tumors.

This update follows May 2021 guidelines which recommended patients with primary biliary cholangitis (PBC) with advanced cirrhosis discontinue obeticholic acid.

PLT012 demonstrates its potential against multiple tumors with unmet medical needs.

Zenocutuzumab-zbco is a bispecific antibody that targets and binds to HER2 and HER3.

The indication is for adults with previously treated unresectable or metastatic HER2+ (IHC+) biliary tract cancer (BTC) as detected by an FDA-approved test.

Advancements include novel combination therapies and improved diagnostic techniques.

Zolbetuximab is the first approved CLDN18.2-targeted treatment for gastric and gastroesophageal junction adenocarcinoma.

Subcutaneous administration of atezolizumab and hyaluronidase-tqjs had similar efficacy to intravenous administration.

The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.

The designation is based off positive results from the RAMP 205 trial presented at the ASCO Annual Meeting.

If approved, zanidatamab will be the first HER2-targeted treatment indicated for individuals with this type of biliary tract cancer.

The authors note that the biomarkers found in the blood were involved in inflammatory processes, immune functions, or vascular processes, and may be pre-diagnostic indicators.

Trastuzumab is indicated for adjuvant breast cancer, metastatic breast cancer, and gastric cancer.

This approval makes lutetium Lu177 the first therapy to be approved for the treatment of gastroenteropancreatic neuroendocrine tumors in pediatric patients.

The designation was granted based on overall survival data from an ongoing randomized phase 2 clinical trial.

Study outcomes demonstrated that 80 HER2-postive BTC individuals enrolled in Cohort 1 of the study achieved a confirmed objective response rate of 41.3%

The orphan drug designation (ODD) is a result of positive findings from a phase 2 clinical trial which demonstrated a 100% clinical benefit rate in patients.

PT886 (Phanes Therapeutics) received fast track designation 2 years after receiving orphan drug designation by the FDA.

For more than 30 years, there has been little treatment advancement for NMIBC patients. Fortunately, a new development in the treatment of NMIBC has been approved by the FDA and is now available.

The approval of irinotecan liposome offers an improved first-line treatment option for individuals diagnosed with metastatic pancreatic adenocarcinoma.