Tremelimumab Plus Durvalumab and Platinum-Based Chemotherapy Approved for Metastatic NSCLC
Lyn Brook
FDA Updates
The FDA has approved tremelimumab (Imjudo®, AstraZeneca) in combination with durvalumab (Imfinzi®, AstraZeneca) and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer (NSCLC) who have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Tremel...
Cemiplimab-rwlc Approved for Treatment of Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted approval of cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for treatment of advanced non–small cell lung cancer (aNSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) aberrations, and no prior systemic...
Selpercatinib Approved for RET Fusion-Positive Non-Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted regular approval selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion non-small cell lung cancer (NSCLC). Selpercatinib previously received an accelerated approval from the FDA based on its initial trial results in May...
Pemigatinib Approved for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement
Lyn Brook
FDA Updates
The FDA has approved pemigatinib (Pemazyre®, Incyte Corporation) for the treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with a fibroblast growth factor receptor 1 (FGFR1) rearrangement. This is the first approval and only targeted treatment for MLNs with a FGFR1 rearrangement. "Myeloid/lymphoid neoplasms with a FGFR1 rearrang...
Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous sy...
Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 ...

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