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In an interview with Targeted Oncology, Vincent Picozzi, MD, discussed the findings that were presented at the 2020 GI Cancers Symposium for patients with pancreatic cancer and how the results could impact the treatment of this patient population. He also highlighted observations from other pancreatic cancer clinical trials and the evolution of the GI cancer landscape as a whole. 

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

Pembrolizumab demonstrated an improvement in progression-free survival in the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer, meeting one of the primary end points of the phase III KEYNOTE-177 trial.

Pembrolizumab demonstrated positive activity in patients with previously treated advanced anal squamous cell carcinoma, regardless of PD-L1 expression, according to the results of the  KEYNOTE-158  trial  presented at the 2020 Gastrointestinal Cancers Symposium.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

The FDA has granted Priority Review to the New Drug Application for ripretinib as treatment of patients with advanced gastrointestinal stromal tumors. This potential FDA approval has a Prescription Drug User Fee Act target action date of August 13, 2020, according to a press release from Deciphera Pharmaceuticals, Inc.<br /> &nbsp;