PIK3CA

FDA approves Itovebi (inavolisib) with palbociclib and fulvestrant for HR+/HER2-negative, PIK3CA-mutated breast cancer, based on INAVO120 study showing 57% lower risk of disease worsening or death.

FDA approves Itovebi (inavolisib) with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer. Based on INAVO120 study, Itovebi-based regimen reduced disease worsening/death risk by 57% vs. palbociclib/fulvestrant alone.

FDA approves Itovebi, a new breast cancer drug for hormone-sensitive, HER2-negative, PIK3CA-mutated cases, doubling progression-free survival to 15 months. Itovebi, inavolisib, is taken with palbociclib and fulvestrant. Common side effects include lab abnormalities, mouth inflammation, diarrhea, fatigue, nausea, rash, decreased appetite, COVID-19 infection, and headache, with a hyperglycemia risk.

FDA approves Itovebi (inavolisib) in combo with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer, based on INAVO120 study showing 57% reduction in disease worsening risk. Itovebi-based regimen more than doubled progression-free survival, maintaining manageable safety and tolerability.

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FDA approves Roche's Itovebi (inavolisib) in combo with Pfizer's Ibrance and AstraZeneca's Faslodex for HR+/HER2- breast cancer. Itovebi, a PI3K inhibitor, outperformed placebo in Phase III INAVO120 trial with 15 months PFS vs 7.3 months. Competitor Novartis's Piqray expected to see lower sales by 2030. Common Grade 3/4 adverse effects include haematological abnormalities and hyperglycaemia.

FDA approves Genentech's Itovebi (inavolisib) for first-line breast cancer treatment, combining it with Pfizer's palbociclib and Astrazeneca's Faslodex for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.

The FDA approved Roche’s Itovebi, a PIK3CA-mutated HR-positive HER2-negative breast cancer treatment, ahead of schedule. Itovebi, in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex, showed a 57% reduction in disease progression risk in the INAVO120 study. Roche anticipates Itovebi’s peak sales at $2.3 billion, challenging Novartis’ Piqray.

The FDA approved Roche’s Itovebi (inavolisib) combined with Ibrance and Faslodex for HR-positive, HER2-negative, PIK3CA-mutated breast cancer, based on the Phase III INAVO120 trial showing significant PFS improvement. The regimen more than doubled PFS and maintained a manageable safety profile, offering a new treatment standard for PIK3CA-mutated breast cancers.

FDA approves Roche’s Itovebi (inavolisib) in combination with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer, based on INAVO120 study results showing a 57% reduction in disease worsening or death risk.