PIK3CA-Related Overgrowth Spectrum Treatments
Find PIK3CA-Related Overgrowth Spectrum Treatments
Medications for PIK3CA-Related Overgrowth Spectrum
These are drugs that have been approved by the US Food and Drug Administration (FDA), meaning they have been determined to be safe and effective for use in PIK3CA-Related Overgrowth Spectrum.
Found 1 Approved Drug for PIK3CA-Related Overgrowth Spectrum
Alpelisib
Brand Names
Vijoice, Piqray
Alpelisib
Brand Names
Vijoice, Piqray
Form: Tablet, Kit, Granule
Method of administration: Oral
FDA approval date: May 24, 2019
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 (PROS) 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(s). 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 (PROS) 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(s). ( 1 )
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