Novartis (NVS) said that the U.S. Food and Drug Administration granted accelerated approval to Vijoice or alpelisib for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum or PROS who require systemic therapy.
Under the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence.
The approval was based on real-world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
PIK3CA-Related Overgrowth Spectrum is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues.
Novartis noted that it will offer patient support program that includes assistance to access medication, financial resources for eligible patients and continued education.
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