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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.
The drug, JNJ-6372, is currently being studied in non-small cell lung cancer patients with EGFR exon 20 insertion mutations.
The positive committee opinion is based on data from the Phase III ALTA-1L trial, which is also supporting the drug's US application for a first-line indication.
Researchers showed that detectable ctDNA following chemoradiation may identify lung cancer patients who will likely have disease recurrence and should receive consolidation immunotherapy.
Pembrolizumab provided long-term overall survival benefit in second-line treatment and can be effectively used for retreatment after disease progression.
The company is seeking to expand the use of the drug as a first-line treatment after it received accelerated approval from the FDA in 2017 for those who failed on Xalkori.