The Food and Drug Administration (FDA) has granted accelerated approval to Lumakras (sotorasib) for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least 1 prior systemic therapy. Sotorasib, an inhibitor of the RAS GTPase family, works by…
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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.
Mobocertinib is an investigational, first-in-class, oral tyrosine kinase inhibitor designed to selectively target EGFR Exon20 insertion mutations.
Progression-free survival significantly longer with tislelizumab plus chemotherapy versus chemotherapy alone
To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.
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.
The Food and Drug Administration has placed sotorasib under priority review for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.