REDUCES OVERGROWTH1
In EPIK-P1, 27% of patients (10/37) (95% CI, 14-44) experienced a response at Week 24 as determined by BICR*†‡
TARGETS THE UNDERLYING CAUSE OF PROS1-7
VIJOICE is an α-selective PI3K inhibitor and does not suppress the immune system
OFFERS 2 DOSAGE FORMS AND 3 ADMINISTRATION OPTIONS1
Once-daily VIJOICE is available in tablets and oral granules§ and can be taken directly by mouth, as a suspension to be taken orally,∥ and as a suspension via feeding tube∥
*The major efficacy outcome measure for the study was the proportion of patients with radiological response at Week 24, which was defined as a ≥20% reduction from baseline in the sum of measurable target lesion volume (1 to 3 lesions) confirmed by at least 1 subsequent imaging assessment, provided that none of the individual target lesions had a ≥20% increase from baseline, nontarget lesions had not progressed, and there were no new lesions.
†Confirmed response as determined by ICRR.
‡Patients without any response assessment at Week 24 were considered nonresponders.
§Only for patients who are prescribed a 50-mg dose.
∥Oral suspension can be prepared from tablets or oral granules. See PI section 2.4 “Vijoice Preparation and Administration Instructions".
BICR, blinded independent central review; FDA, US Food and Drug Administration; ICRR, independent central radiology review; PI3K, Phosphoinositide 3-kinase; PROS, PIK3CA-Related Overgrowth Spectrum.
†Confirmed response as determined by ICRR.
‡Patients without any response assessment at Week 24 were considered nonresponders.
§Only for patients who are prescribed a 50-mg dose.
∥Oral suspension can be prepared from tablets or oral granules. See PI section 2.4 “Vijoice Preparation and Administration Instructions".
BICR, blinded independent central review; FDA, US Food and Drug Administration; ICRR, independent central radiology review; PI3K, Phosphoinositide 3-kinase; PROS, PIK3CA-Related Overgrowth Spectrum.