GI Cancers

Liposomal Irinotecan Combo Granted FDA Fast Track Designation for Advanced PDAC

June 17, 2020

A liposomal irinotecan combination was granted FDA Fast Track designation for the treatment of untreated and unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.

CD40 Agonist Plus Chemotherapy Hypothesized to Improve Outcomes in Metastatic PDAC

June 16, 2020

In an interview with Targeted Oncology, Andrew L. Coveler, MD, discussed the phase 1 trial study of SEA-CD40 combined with a chemotherapy regimen, which he recently presented during the ASCO Virtual Scientific Program.

FDA Grants Orphan Drug Designation to DKN-01 for Gastric/GEJ Cancer

June 12, 2020

"We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area of high unmet medical need."

FDA Approves Nivolumab for Unresectable Esophageal Squamous Cell Carcinoma

June 11, 2020

The FDA granted approval to nivolumab for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after receiving prior fluoropyrimidine- and platinum-based chemotherapy.

Margetuximab Gains FDA Orphan Drug Designation in Gastric/GEJ Cancer

June 05, 2020

The FDA has granted margetuximab an orphan drug designation for the treatment of patients with gastric and gastroesophageal junction cancer.

Significant Disease Control Achieved With Nivolumab/Temozolomide Combo in Neuroendocrine Tumors

May 27, 2020

“Although these are early data, we are encouraged by these findings. The depth of response is particularly impressive in some patients."

Immunotherapy-Based Combos May be Necessary in Neuroendocrine Neoplasms

May 22, 2020

The immune checkpoint inhibitor induced 1 objective response but appeared safe as treatment of patients with metastatic high-grade neuroendocrine neoplasms in 2 open-label phase 2 clinical trials.

Trastuzumab Deruxtecan Receives Orphan Drug Designation from FDA for Gastric Cancer

May 22, 2020

Fam-trastuzumab deruxtecan-nxki has received an Orphan Drug designation for the treatment of patients with gastric or gastroesophageal junction cancer.

Pembrolizumab Shows Durable Response in Advanced Unresectable Anal Cancer

May 19, 2020

Van K. Morris, MD, discusses the findings of the KEYNOTE-158 trial, which evaluated pembrolizumab in advanced solid tumors in relation to patients with advanced unresectable anal cancer.

FDA Denies Approval of Avapritinib in Fourth-Line GIST

May 15, 2020

The New Drug Application for avapritinib as treatment of unresectable or metastatic fourth-line gastrointestinal stromal tumor was refused by the FDA, according to a recently issued complete response letter.