Tag: NSCLC

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Neoadjuvant/ adjuvant pembrolizumab is approved by the FDA for resectable non-small cell lung cancer
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Neoadjuvant/ adjuvant pembrolizumab is approved by the FDA for resectable non-small cell lung cancer

Nov 2023: Pembrolizumab (Keytruda, Merck) was granted approval by the Food and Drug Administration (FDA) as a neoadjuvant treatment in combination with platinum-containing chemotherapy and as a post-surgical adjuvant treatment f..

Gavreto
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Pralsetinib is approved by the FDA for non-small cell lung cancer with RET gene fusions

August 2023: Pralsetinib (Gavreto, Genentech, Inc.) was given regular approval by the Food and Drug Administration for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as determined by an FDA..

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Adagrasib gets accelerated approval for KRAS G12C-mutated NSCLC

Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, was given accelerated approval by the Food and Drug Administration (FDA) for adult patients with KRAS G12C-mutated locally advanced or metast..

Tremelimumab is approved by FDA
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Tremelimumab is approved by FDA in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

November 2022: The combination of tremelimumab (Imjudo, AstraZeneca Pharmaceuticals), durvalumab (Imfinzi, AstraZeneca Pharmaceuticals), and platinum-based chemotherapy was approved by the Food and Drug Administration for adult pa..

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Cemiplimab-rwlc is approved by FDA in combination with platinum-based chemotherapy for non-small cell lung cancer

November 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 abnormalit..

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Capmatinib is approved for metastatic non-small cell lung cancer

August 2022: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation resulting in mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test, the Food..

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Neoadjuvant nivolumab and platinum-doublet chemotherapy is approved for early-stage non-small cell lung cancer

March 2022: In the neoadjuvant setting, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC).Thi..

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Atezolizumab is approved by FDA as adjuvant treatment for non-small cell lung cancer

Nov 2021: The Food and Drug Administration has approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours contain PD-L1 expression o..

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Lorlatinib has been approved by the FDA for the treatment of metastatic ALK-positive NSCLC

August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) received regular FDA approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, as determined by an FDA-app..

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Cemiplimab-rwlc has been approved by the FDA for non-small cell lung cancer with high PD-L1 expression

August 2021: The FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgic..

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