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FDA Approves Isatuximab-irfc With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
On September 20, the US Food and Drug Administration (FDA) approved isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
For more information read the FDA announcement and the Sanofi-Aventis US LLC announcement.
Posted on 9/23/2024
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FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Select Patients With Non-Small Cell Lung Cancer
On September 19, the US Food and Drug Administration (FDA) approved amivantamab-vmjw with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
For more information read the FDA announcement and the Johnson & Johnson announcement.
Posted on 9/20/2024
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FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
On September 17, the US Food and Drug Administration (FDA) approved pembrolizumab with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.
For more information read the FDA announcement and the Merck announcement.
Posted on 9/19/2024
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FDA Approves Ribociclib With an Aromatase Inhibitor and the Ribociclib and Letrozole Co-Pack for Early High-Risk Breast Cancer
On September 17, the US Food and Drug Administration (FDA) approved ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication.
For more information read the FDA announcement and the Novartis Pharmaceuticals Corporation announcement.
Posted on 9/19/2024
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FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection
On September 12, the US Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
For more information read the FDA announcement and the Genentech, Inc. announcement.
Posted on 9/19/2024
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FDA Grants Fast Track Designation to BGB-16673
On August 26, the US Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase targeting chimeric degradation activation compound, for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have been previously treated with at least two prior lines of therapy, including BTK inhibitor and B-cell lymphoma 2 inhibitor.
For more information read the BeiGene announcement.
Posted on 8/26/2024
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FDA Approves Lazertinib With Amivantamab-vmjw for Non-Small Cell Lung Cancer
On August 19, the US Food and Drug Administration (FDA) approved lazertinib in combination with amivantamab-vmjw for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
For more information read the FDA announcement.
Posted on 8/21/2024
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FDA Approves Neoadjuvant/Adjuvant Durvalumab for Resectable Non-Small Cell Lung Cancer
On August 15, the US Food and Drug Administration (FDA) approved durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
For more information read the FDA announcement and the AstraZeneca announcement.
Posted on 8/21/2024
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FDA Approves Axatilimab-csfr for Chronic Graft-Versus-Host Disease
On August 14, the US Food and Drug Administration (FDA) approved axatilimab-csfr, a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
For more information read the FDA announcement and the Incyte Corporation announcement.
Posted on 8/19/2024
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FDA Approves Daratumumab and Hyaluronidase-fihj for Select Patients with Multiple Myeloma
On July 30, the US Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
For more information read the FDA announcement and the Johnson & Johnson announcement.
Posted 7/31/2024