Daiichi Sankyo and ArQule announced that the first patient has been enrolled in the Phase 3 trial of ARQ 197 in combination with erlotinib, for patients diagnosed with non-squamous, non-small cell lung cancer (NSCLC) who have received one or two prior systemic anti-cancer therapies.
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Alder Biopharmaceuticals announced that patients with late-stage non-small cell lung cancer (NSCLC) showed improvement in cancer-related anemia and symptoms of the disease in a Phase 2a clinical trial of ALD518.
ArQule and Daiichi Sankyo announced the presentation of data from a Phase 2 trial showing encouraging overall survival (OS) results with ARQ 197 in combination with erlotinib among patients with advanced, refractory non-small cell lung cancer (NSCLC).
The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
The approval of Imfinzi is based on the positive PFS data from the Phase 3 PACIFIC trial.
Genentech announced that the Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
Chemotherapeutic and biologic agents for the treatment of non-small cell lung cancer (NSCLC).
The FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib; Pfizer).
The US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib; AstraZeneca) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
The FDA has approved Gilotrif (afatinib) with the therascreen EGFR RQG PCR kit for the treatment of metastatic non-small cell lung carcinoma in patients whose tumors have certain EGFR gene mutations detected by the FDA-approved diagnostic test.