The approval is based on a Phase III trial showing that Tecentriq significantly improved survival in patients with metastatic non-small cell lung cancer.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
This is the first anti-PD-1 drug approved for front-line treatment of advanced and unresectable, recurrent head and neck cancer in the EU.
Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
Roche noted that it expects the European Commission to approve trastuzumab emtansine in the near future, based on the EMA committee's recommendation.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.