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Celcuity
NEWS

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
June 3, 2026

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NEWS

Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 

Shots:  The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy  EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
May 21, 2026

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Roche
NEWS

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Shots:    The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial  P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…
October 11, 2024

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