News
The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
News
The FDA has approved Tecentriq in combination with chemotherapy (Abraxane [paclitaxel protein-bound, nab-paclitaxel; Celgene] and carboplatin) for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations.
News
Results from the phase 3 RELAY trial of ramucirumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in previously untreated patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC) compared with erlotinib alone, according to a study published in The Lancet Oncology. The multicenter, double-blind, placebo-controlled study evaluated the efficacy and…
News
The FDA has approved Gavreto™ (pralsetinib; Blueprint Medicines and Genentech) for the treatment of adults with metastatic RET fusion-positive NSCLC.
News
The FDA has approved Alunbrig® (brigatinib; Takeda) as a first-line treatment of adults with anaplastic lymphoma kinase(ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Drugs in the Pipeline
Topline results from the trial showed that compared with chemotherapy, treatment with cemiplimab-rwlc reduced the risk of death by 32% in the overall trial population.
News
Genentech announced positive data from the phase 3 IMpower110 study of atezolizumab as first-line monotherapy in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT). IMpower110 is an open-label, randomized study comparing the efficacy and safety of atezolizumab monotherapy to chemotherapy consisting of either cisplatin or carboplatin plus…
Drugs in the Pipeline
Sanofi and Regeneron announced that the phase 3 trial evaluating cemiplimab (Libtayo®) as a potential first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer was stopped early due to “highly significant improvement” in overall survival.
News
The Food and Drug Administration (FDA) has approved updated labeling for Imfinzi (durvalumab; AstraZeneca) to include overall survival data for patients with unresectable, Stage III non-small cell lung cancer (NSCLC). The update was based on data from the phase 3, double blind, multicenter PACIFIC trial that evaluated the efficacy of durvalumab in 713 adult patients…
Drugs in the Pipeline
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.