The agency based its decision on a trial showing that patients receiving the combo had a median PFS of 19.4 months versus 12.4 months for those on Tarceva.
However, the translational biomarker analysis suggested that high HER2 expression after neoadjuvant treatment may signal resistance to adjuvant Herceptin.
The companies plan to enroll 1,000 patients with lung cancer to assess whether technology-enabled trial enrollment can expand access to precision oncology to more patients.
The prospective study will combine real-world, clinical, and genomic data to streamline lung cancer clinical trials and find treatment-response biomarkers.
Several genomic markers were associated with improved progression-free survival among patients treated with Tecentriq and Avastin versus Tecentriq alone.
In two studies, researchers showed the benefit of combining Tecentriq, Cotellic, and Zelboraf and sticking with continuous versus intermittent dosing of targeted drugs.
In the pivotal trial that led to its approval, the drug in combination with Herceptin and capecitabine showed promising activity in HER2-positive, breast cancer patients with brain metastasis.
