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Da Hee Han, PharmD remove

Your search for non small cell lung cancer returned 13 results

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Tecentriq Approved for Non-Small Cell Lung Cancer

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.
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Companion Dx Test for Iressa Receives Marketing Approval

Qiagen announced that it has received marketing approval for its therascreen EFGR RGQ PCR Kit as a companion diagnostic to Iressa (geftinib; AstraZeneca) for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC).
Drugs in the Pipeline

Brigatinib NDA Accepted for FDA Review

ARIAD announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brigatinib to treat patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib.
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FDA Grants Accelerated Approval for Keytruda in HNSCC

Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Drugs in the Pipeline

FDA to Review Opdivo for Urothelial Carcinoma Use

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for Priority Review.
Drugs in the Pipeline

Imfinzi Designated Breakthrough Therapy for NSCLC

Imfinzi, an anti-PD-L1 monoclonal antibody, was previously granted accelerated approval from the FDA for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.