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FDA Approves Inotuzumab Ozogamicin for Pediatric Patients with Acute Lymphoblastic Leukemia
On March 6, the US Food and Drug Administration (FDA) approved inotuzumab ozogamicin for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
For more information read the FDA announcement.
Posted 3/8/2024
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FDA Approves Amivantamab-vmjw for Non-small Cell Lung Cancer
On March 1, the US Food and Drug Administration (FDA) approved amivantamab-vmjw in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test.
For more information read the FDA announcement and the Janssen announcement.
Posted 3/8/2024
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FDA Approves Osimertinib + Chemotherapy for EGFR-mutated Non-small Cell Lung Cancer
On February 16, the US Food and Drug Administration (FDA) approved osimertinib in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
For more information read the FDA announcement and the AstraZeneca Pharmaceuticals announcement.
Posted 2/19/2024
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FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma
On February 16, the US Food and Drug Administration (FDA) granted accelerated approval to lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
For more information read the FDA announcement and the Iovance Biotherapeutics, Inc. announcement.
Posted 2/19/2024
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FDA Approves Tepotinib for Metastatic non-small Cell Lung Cancer
On February 15, the US Food and Drug Administration (FDA) granted traditional approval to tepotinib for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.
For more information read the FDA announcement.
Posted 2/16/2024
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FDA Approves Irinotecan Liposome for First-line Treatment of Metastatic Pancreatic Adenocarcinoma
On February 13, the US Food and Drug Administration (FDA) approved irinotecan liposome in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
For more information read the FDA announcement.
Posted 2/13/2024
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FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma
On January 19, the US Food and Drug Administration (FDA) approved erdafitinib for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
For more information read the FDA announcement and the Janssen announcement.
Posted 1/22/2024
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FDA Approves Pembrolizumab + CRT for FIGO 2014 Stage III-IVA Cervical Cancer
On January 12, the US Food and Drug Administration (FDA) approved pembrolizumab with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
For more information read the FDA announcement and the Merck announcement.
Posted 1/15/2024
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FDA Approves Iptacopan for Patients with Paroxysmal Nocturnal Hemoglobinuria
On December 5, the US Food and Drug Administration (FDA) approved iptacopan—offering superior hemoglobin improvement in the absence of transfusions—as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
For more information read the Novartis announcement.
Posted 12/18/2023
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FDA Approves Enfortumab vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer
On December 15, the US Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.
For more information read the FDA announcement, Astellas Pharma announcement, and Merck announcement.
Posted 12/18/2023