Industry News

FDA Approves Updated Drug Labeling for Fludarabine phosphate Under Project Renewal

On November 19, the US Food and Drug Administration (FDA) approved updated drug labeling for fludarabine phosphate under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
For more information read the FDA announcement.
Posted on 11/20/2024

FDA Approves Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

On November 15, the US Food and Drug Administration (FDA) approved revumenib, a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation in adult and pediatric patients 1 year and older.
For more information, read the FDA announcement.
Posted on 11/20/2024

FDA Approves Obecabtagene autoleucel for Adults With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

On November 8, the US Food and Drug Administration (FDA) approved obecabtagene autoleucel, a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
For more information read the FDA announcement.
Posted on 11/14/2024

FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia

On October 29, the US Food and Drug Administration (FDA) granted accelerated approval to asciminib for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
For more information read the FDA announcement.
Posted on 10/29/2024

New Insurance Codes for Scalp Cooling Will Transform Access for Cancer Patients

On October 18, the American Medical Association introduced new Category I Current Procedural Terminology codes for scalp cooling services, effective January 2026. This change will enhance insurance reimbursement, making scalp cooling more accessible to cancer patients undergoing chemotherapy.
For more information read the PR Newswire announcement.
Posted on 10/24/2024

FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer

On October 15, the US Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
For more information read the Novocure announcement.
Posted on 10/24/2024

FDA Approves Zolbetuximab-clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

On October 18, US the Food and Drug Administration (FDA) approved zolbetuximab-clzb, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
For more information read the FDA announcement.
Posted on 10/21/2024

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Select Patients With Breast Cancer

On October 10, the US Food and Drug Administration (FDA) approved inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
For more information read the FDA announcement and the Genentech, Inc. announcement.
Posted on 10/17/2024

FDA Approves Neoadjuvant/Adjuvant Nivolumab for Resectable Non-Small Cell Lung Cancer

On October 3, the US Food and Drug Administration (FDA) approved nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, 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.
Posted on 10/8/2024

FDA Approves Selpercatinib for Medullary Thyroid Cancer With a RET Mutation

On September 27, the US Food and Drug Administration (FDA) granted traditional approval to selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
For more information read the FDA announcement.
Posted on 10/7/2024

FDA Approves Osimertinib for Locally Advanced, Unresectable Non-Small Cell Lung Cancer Following Chemoradiation Therapy

On September 25, the US Food and Drug Administration (FDA) approved osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and 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.
Posted on 9/26/2024

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

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

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

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

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

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

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

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

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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Industry News

FDA Approves Updated Drug Labeling for Fludarabine phosphate Under Project Renewal

FDA Approves Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

FDA Approves Obecabtagene autoleucel for Adults With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia

New Insurance Codes for Scalp Cooling Will Transform Access for Cancer Patients

FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer

FDA Approves Zolbetuximab-clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Select Patients With Breast Cancer

FDA Approves Neoadjuvant/Adjuvant Nivolumab for Resectable Non-Small Cell Lung Cancer

FDA Approves Selpercatinib for Medullary Thyroid Cancer With a RET Mutation

FDA Approves Osimertinib for Locally Advanced, Unresectable Non-Small Cell Lung Cancer Following Chemoradiation Therapy

FDA Approves Isatuximab-irfc With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Select Patients With Non-Small Cell Lung Cancer

FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

FDA Approves Ribociclib With an Aromatase Inhibitor and the Ribociclib and Letrozole Co-Pack for Early High-Risk Breast Cancer

FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection

FDA Grants Fast Track Designation to BGB-16673

FDA Approves Lazertinib With Amivantamab-vmjw for Non-Small Cell Lung Cancer

FDA Approves Neoadjuvant/Adjuvant Durvalumab for Resectable Non-Small Cell Lung Cancer

FDA Approves Axatilimab-csfr for Chronic Graft-Versus-Host Disease