Gastrointestinal 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.

“I see clinical pharmacy specialists (CPS) to be more like the frontline folks that would pretty much work very closely with the providers,” according to a CPS at City of Hope.

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.

This review summarizes current utilization of anti-HER2 targeted therapy across several non-breast solid tumors in the setting of advanced disease.

Compared to TACE alone, durvalumab plus TACE and bevacizumab reduced the risk of disease progression or death by 23%; however, further research is needed to assess OS.

There was no statistically significant difference between Lovenox (Sanofi–Aventis Pharmaceuticals, France) and biosimilar enoxaparin in the occurrence of post-operative thrombosis for digestive cancer.