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The FDA approved the PI3K-pathway inhibitor inavolisib (Itovebi) for use in combination with palbociclib (Ibrance) and fulvestrant to treat locally advanced, PIK3CA-mutated, hormone receptor (HR)-positive/HER2-negative breast cancer that recurred during or after adjuvant endocrine therapy. Support for the approval came from the multicenter randomized INAVO120 trial, which showed that the addition of inavolisib to palbociclib […]

MedPage Today

New York

United States

PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer

In the approval trial, Genentech's PI3K inhibitor doubled progression-free survival compared with placebo.

Medscape

FDA Approves Inavolisib for HR+, HER2−, Advanced Breast Cancer With PIK3CA Mutation

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Media Bias/Fact Check

– Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting – – This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis – – Itovebi is Genentech’s first…

pipelinereview

FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation - Pipelinereview

FDA approves Itovebi for advanced breast cancer: Roche's new treatment doubles progression-free survival in PIK3CA-mutated cases. Learn how this targeted therapy could impact 40% of HR+ patients.

stocktitan.net

FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Background 
CDK4/6 inhibitors are the standard of care for HR+/HER2-negative metastatic breast cancer in combination with endocrine therapy. However, the real-world efficacy and safety of standard versus reduced doses in elderly patients remain unclear. This study aims to compare the clinical outcomes of standard versus reduced doses of CDK4/6 inhibitors in elderly patients with metastatic breast cancer.
Methods
This multicenter retrospective co…

preprints.org

Standard versus Reduced CDK4/6 Inhibitor Therapy in Elderly Patients with Metastatic Hormone Receptor‐Positive, HER2‐Negative Breast Cancer: An Observational Multicenter Study

The FDA approved inavolisib plus palbociclib/fulvestrant for select PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer.

onclive.com

FDA Approves Inavolisib Plus Palbociclib/Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, HR+, HER2– Advanced Breast Cancer

The FDA has approved Roche’s inavolisib plus Pfizer’s Ibrance and fulvestrant in a subtype of breast cancer over a month before the target action date, the agency announced Thursday. The treatment, which will be marketed as Itovebi and costs $22,867 for a 28-day course of treatment, is now approved for adults with endocrine-resistant, locally advanced or metastatic, PIK3CA-mutated HR-positive HER2-negative breast cancer when used in combination …

Endpoints News

Updated: FDA approves Roche's new treatment for subset of breast cancer patients

The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients who would benefit from the treatment.

Pharmacy Times

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Breast Cancer

Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after recurrence or completing adjuvant endocrine therapy.

ajmc.com

FDA Approves Inavolisib in Locally Advanced, Metastatic Breast Cancer

The approval of inavolisib is supported by findings from the phase 3 INAVO120 study evaluating the agent plus palbociclib and fulvestrant.

PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer

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