GI CANCERS

The FDA accepted a supplemental new drug application for ivosidenib tablets and granted it priority review for the treatment of patients with previously treated IDH1-mutated cholangiocarcinoma.

A rolling submission of a new drug application to the FDA has been initiated for surufatinib as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

In an interview with Targeted Oncology, Mark E. Johns, MD, discussed landmark esophageal cancer studies, newly approved treatments, and the future of the space.

Although chemotherapy is the mainstay of systemic treatment for advanced cholangiocarcinoma, there are limited treatment options when the disease progresses

The FDA has granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2b overexpression or amplification.

The FDA has lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.

The FDA has approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck.

Bassel El-Rayes, MD, an expert in oncology, discusses the DESTINY-Gastric01 trial of trastuzumab deruxtecan in HER2+ gastric cancer and comments on implications for second-line treatment and beyond.

In an interview with Targeted Oncology, Axel Grothey, MD, discussed how HER2 has become an actionable target for gastrointestinal cancers and potential HER2-targeted treatments in the field as well as other interesting studies from the role trastuzumab plays in the space.

A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes.

A key advance in treating patients with gastrointestinal cancer is molecular profiling of the tumor that results in specific targets being identified. The standard of care for GI cancer has consisted of surgery, radiotherapy, and chemotherapy, but these standards have had limited efficacy and considerable toxicity that impact patients’ quality of life.

The use of a fitness tracking device as a prognostic tool was feasible and acceptable in a study evaluating 80 patients with colorectal cancer.

Half of all patients with hepatocellular carcinoma treated with the combination of regorafenib and nivolumab following progression on 2 lines of chemotherapy achieved disease control, according to initial results from a phase 2 proof-of-concept trial.

The FDA has approved pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy for the treatment of patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who are not eligible for surgical resection or definitive chemoradiation.

The modified Appleby procedure, a technique that removes two-thirds of the pancreas, the spleen, and the celiac axis, offers patients with pancreatic cancer another treatment option.

James Harding, MD, discusses the need for genomic testing in biliary tract cancers.

The FDA has approved TheraSphere yttrium-90 glass microspheres for the treatment of patients with unresectable hepatocellular carcinoma.

Bintrafusp alfa monotherapy demonstrated efficacy, durability, and a manageable safety profile in patients with locally advanced or metastatic biliary tract cancer who have progressed or are intolerant to first-line platinum-based chemotherapy in a phase 2 study, but failed to meet the pre-determined threshold for a regulatory filing.

The FDA has granted an orphan drug designation to ARX788 for the treatment of patients with HER2-positive gastric cancer, according to a press release from developer Ambrx.