GIST

Neeta Somaiah, MD, reviews the case of a 68-year-old man with gastrointestinal stromal tumor.

“The data presented today further reinforce the potential of ripretinib to provide meaningful clinical benefit to patients with advanced gastrointestinal stromal tumor."

Key opinion leaders discuss the evolving treatment paradigm for relapsed/refractory gastrointestinal stromal tumors, and provide an overview of supplemental data presented at the ASCO (American Society of Clinical Oncology) 2020 Annual Meeting.

"Today’s approval of Qinlock establishes a new standard of care for patients who have received three prior therapies."

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.

"While we are disappointed by the outcome of the VOYAGER trial, we are deeply grateful to the patients, investigators, and clinical site staff who contributed to the completion of this global study."

Margaret von Mehren, MD, discusses ripretinib and how it works in patients with heavily pretreated advanced gastrointestinal stromal tumors.

Despite demonstrating improvement in overall survival as treatment of patients with advanced inoperable metastatic colorectal cancer, cetuximab plus chemotherapy led to significantly worse survival for patients with operable colorectal liver metastases in the perioperative setting, according to findings from randomized phase III clinical trial.

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;

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

The FDA has extended the Prescription Drug User Fee Act date by 3 months for the new drug application of avapritinib from February 14, 2020, to May 14, 2020, the manufacturer, Blueprint Medicines Corporation, announced in a news release.&nbsp;The NDA was seeking accelerated approval for the kinase inhibitor for the treatment of adults with fourth-line gastrointestinal stromal tumors.