Turning Point Gets FDA Orphan Designation for TPX-0022 in Gastric Cancer

By Colin Kellaher

Turning Point Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its MET inhibitor TPX-0022 for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma.

The San Diego clinical-stage oncology company said there are currently no approved MET inhibitors for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Turning Point said TPX-0022 was generally well-tolerated and showed clinical activity in a Phase 1 study in patients with MET-amplified gastric cancer.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 17, 2021 09:06 ET (13:06 GMT)

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