TPTX - Turning Point Therapeutics gets FDA orphan drug status for TPX-0022 in gastric cancer

Turning Point Therapeutics (TPTX) announces that TPX-0022 has been granted orphan drug designation by the U.S. FDA for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma.TPX-0022 is a potent inhibitor of the MET tyrosine kinase and has the potential to modulate the tumor microenvironment to augment its therapeutic effect.Initial clinical data from an early-stage trial showed that TPX-0022 has been generally well-tolerated and demonstrated clinical activity in patients with MET-amplified gastric cancer.Orphan Drug Designation is granted by the FDA to assist in the development of drug candidates that may offer therapeutic benefits for diseases with a prevalence of fewer than 200K patients annually.Benefits of the designation may include the opportunity for accelerated approval, and eligibility for 7 years of market exclusivity post-regulatory approval, among others.

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Turning Point Therapeutics gets FDA orphan drug status for TPX-0022 in gastric cancer