Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
FDA Approves Genentech's Itovebi Combo for PIK3CA-Mutated Advanced Breast Cancer Patients
In the INAVO120 trial, Itovebi added to Pfizer's Ibrance and fulvestrant doubled progression-free survival versus Ibrance and fulvestrant alone.
In Brief This Week: ADLM, Verismo, Gemma, Denovo, Flatiron Health, Foresight, Naveris
News items for the week of Oct. 7, 2024.
Foundation Medicine Test Approved by FDA as CDx for Itovebi in Breast Cancer Patients
The test is approved for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
Burning Rock, Dizal Get Chinese Approval for Lung Cancer CDx
The test, approved by Chinese regulators in early 2022, is designed for the detection of multiple mutation statuses for nine genes.
Roche CDx Test Receives CE Marking for Use in Gastric Cancer Patients
The IHC companion diagnostic test determines CLDN18 protein expression and may help identify patients who are eligible for treatment with Vyloy.
Sep 19, 2024