EMA Marketing Authorization of New Drugs in July 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…

ByDipanshu DixitAugust 19, 2025

NEWS

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots:The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trialTrial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

ByRidhi RastogiJuly 23, 2025

NEWS

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Shots:The CHMP has recommended Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trialTrial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, improved PFS (1EP) by…

ByRidhi RastogiMay 26, 2025

NEWS

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Shots:The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…

ByDipanshu DixitJanuary 30, 2025

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=…

ByDipanshu DixitOctober 11, 2024

EMA Marketing Authorization of New Drugs in July 2025

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

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

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