Generic Name

Alpelisib

Brand Names
Vijoice, Piqray
FDA approval date: May 24, 2019
Form: Tablet, Kit, Granule

What is Vijoice (Alpelisib)?

VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. VIJOICE is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

Study Assessing the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

Summary: This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study

Summary: The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the hyperglycemic clamp. Participants will come in for a two-day (overnight) visit in which they will first undergo a hyperglycemic clamp, in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to mea...

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Summary: This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment t...

Brand Information