An interim analysis of the IMpower110 study showed that the drug performed better as a first-line treatment than chemotherapy in these patients.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The drugmaker will present data from the Impower110 trial at an upcoming meeting and submit the data to regulatory authorities.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The recommendation is based on a study in which NSCLC patients without EGFR mutations or ALK rearrangements lived longer on the combo than just on chemo.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
CHMP endorsed the immunotherapy combination for women in Europe with triple-negative, advanced cancers based on results from a Phase III trial reported last December.
Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical.
Combined DNA/RNA-seq efforts in various settings could lead to new ways of treating kids with drugs meant for adults or to the development of new therapies.