The approval is based on a Phase III trial showing that Tecentriq significantly improved survival in patients with metastatic non-small cell lung cancer.
More individuals treated with BRAF- and MEK-targeted drugs were still alive after four years than would be expected with conventional chemo drugs.
IMvigor130 data suggests atezolizumab plus chemotherapy delays progression in urothelial carcinoma, with potential survival benefit seen in PD-L1 subgroup treated with monotherapy.
A collection of biomarker- and genomic testing-driven precision oncology research presented at the European Society of Medical Oncology Congress.
An interim analysis of the IMpower110 study showed that the drug performed better as a first-line treatment than chemotherapy in these patients.
The drugmaker will present data from the Impower110 trial at an upcoming meeting and submit the data to regulatory authorities.
This is the third drug the agency has approved with a pan-cancer indication.
Progression-free survival times were comparable for EGFR-mutated non-small cell lung cancer cases treated with a combination of erlotinib and bevacizumab treatment or erlotinib.
The successful development of new targeted tissue-agnostic cancer drugs will be tied to the use of real-world data and new clinical trial formats.
In the Phase I/IB study, only patients with NTRK or ROS1 fusions, or an ALK fusion or mutation responded to entrectinib, while patients without these tumor markers didn’t respond.