The approval was based on data from the phase 1 CHRYSALIS trial that evaluated Rybrevant in 81 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.
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Mobocertinib is an investigational, first-in-class, oral tyrosine kinase inhibitor designed to selectively target EGFR Exon20 insertion mutations.
The phase 3 trial evaluated the efficacy and safety of cemiplimab in women 18 years of age and older with recurrent or metastatic cervical cancer, including those with either squamous cell carcinoma or adenocarcinoma.
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to interleukin-1beta.
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.
Results showed the median OS was 21.4 months in the pembrolizumab plus ipilimumab arm compared with 21.9 months in the pembrolizumab monotherapy arm.
The approval was based on data from an open-label phase 1/2 trial in patients aged 1 to 21 years that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and blocking its interaction with the poliovirus receptor.
The sNDA is supported by data from the phase 3 CROWN study comparing lorlatinib to Xalkori in 296 adults with advanced ALK-positive NSCLC.