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In a Phase I trial, non-small cell lung cancer patients with exon 20 insertions experienced durable responses with amivantamab.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial.
Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab.
This approval, based on the part 1a results from the Phase III CheckMate-227 trial, is the fifth indication for this drug combination.
Based on the three-year overall survival and PFS rate, Bristol Myers Squibb intends to seek FDA approval for the combination in first-line, PD-L1 positive, NSCLC patients.
The company will now initiate the dose escalation portion of a Phase I/II study and will enroll 90 NSCLC patients in the country.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
Researchers at the University Medical Center Groningen published results showing that most lung cancer patients' treating doctors followed the therapy recommendations of the expert body.