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The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.
Deleterious NOTCH mutations may predict more favorable immune checkpoint responses in lung cancer patients without EGFR or ALK mutations.
Top-line results from the first part of the Atalante 1 trial showed the company's investigational product Tedopi produced a 12-month survival rate of 46 percent.
The company announced that it is planning to submit an NDA for the drug in RET-mutant medullary thyroid cancer.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 15 skipping alterations.
The Chinese drug evaluation agency has granted the investigational new drug clinical trial authorization to taletrectinib in NRTK- and ROS1-mutated cancer patients.
The drug, Amelie, will be for the second-line treatment of EGFR T790-mutated non-small cell lung cancer.
The companies initially plan to validate biomarkers for use with the Oncomine Dx Target Test to identify NSCLC patients for enrollment into clinical trials.