Pembrolizumab Approved for Adjuvant Treatment of Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observat...
Enhancing Knowledge of Small Cell Lung Cancer Treatment and Management
Keira Smith
Practice Patterns
An educational activity offered by i3 Health has provided significant knowledge gains regarding strategies to enhance the clinical outcomes of patients with extensive-stage small cell lung cancer (SCLC) Among the 238,340 new cases of lung cancer reported in the United States each year, approximately 14% of cases are classified as small cell, a more...
Pafolacianine Approved for Detection of Lung Cancer Lesions
Keira Smith
FDA Updates
The FDA has approved a new indication for pafolacianine (Cytalux®, On Target Laboratories), a diagnostic agent, for the identification of lung cancer lesions in adult patients with known or suspected lung cancer who are undergoing surgery. Administered intravenously prior to surgery, pafolacianine is designed to locate additional hard-to-detect lun...
Adagrasib Approved for KRAS G12C–Mutated Non–Small Cell Lung Cancer
Lyn Brook
FDA Updates
The FDA has granted accelerated approval to adagrasib (Krazati™, Mirati Therapeutics, Inc.) for treatment of adult patients with kirsten rat sarcoma viral oncogene homologue (KRAS) G12C–mutated locally advanced or metastatic non­–small cell lung cancer (NSCLC). Patients should have received one prior line of systemic therapy. Adagrasib is a rat sar...
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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