FDA Approves Blinatumomab for 72- and 96-Hour Infusion Durations

On December 17, the US Food and Drug Administration approved blinatumomab for 72- and 96-hour infusion durations to offer more flexibility for physicians and their patients.

For more information visit the BLINCYTO website.

Posted on 12/23/2024

FDA Grants Accelerated Approval to Encorafenib With Cetuximab and mFOLFOX6 for Metastatic Colorectal Cancer With a BRAF V600E Mutation

On December 20, the US Food and Drug Administration granted accelerated approval to encorafenib with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

For more information read the FDA announcement and the Array BioPharma press release.

Posted on 12/23/2024

FDA Approves Remestemcel-L-rknd for Steroid-Refractory Acute Graft Versus Host Disease in Pediatric Patients

On December 18, the US Food and Drug Administration approved remestemcel-L-rknd, an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.

For more information read the FDA announcement and visit the Mesoblast website.

Posted on 12/23/2024

FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On December 18, the US Food and Drug Administration approved ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.

For more information read the FDA announcement and visit the Xcovery Holdings website.

Posted on 12/23/2024

FDA Approves Cosibelimab-ipdl for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

On December 13, the US Food and Drug Administration approved cosibelimab-ipdl, a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 

For more information read the FDA announcement and the Checkpoint Therapeutics press release.

Posted on 12/23/2024

FDA Approves Durvalumab for Limited-Stage Small Cell Lung Cancer

On December 4, the US Food and Drug Administration (FDA) approved durvalumab for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

For more information, read the FDA announcement or the AstraZeneca press release.

Posted on 12/6/2024

FDA Grants Accelerated Approval to Zenocutuzumab-zbco for Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma

On December 4, US the Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab-zbco for adults with the following:

• advanced, unresectable, or metastatic non-small cell lung cancer harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
• advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

For more information, read the FDA announcement or the Merus N.V. press release. 

Posted on 12/6/2024

FDA Grants Accelerated Approval to Zanidatamab-hrii for Select Cases of Biliary Tract Cancer

Posted on 11/22/2024

On November 20, the US Food and Drug Administration (FDA) granted accelerated approval to zanidatamab-hrii, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive IHC 3+ biliary tract cancer, as detected by an FDA-approved test.

For more information read the FDA announcement and the Jazz Pharmaceuticals press release.

FDA Approves Updated Drug Labeling for Fludarabine phosphate Under Project Renewal

Posted on 11/20/2024

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 and visit the Sandoz website.

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

Posted on 11/20/2024

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 and the Syndax Pharmaceuticals press release.

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

Posted on 11/14/2024

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 and visit the Autolus website.

Anemia in Focus: The Challenge of Identifying Myelodysplastic Syndromes (MDS)

Posted on 11/09/2024

Anemia is a hallmark of MDS, conferring heightened mortality risk and diminished quality of life. Please feel free to view & share this important resource.
View Resource

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

Posted on 10/29/2024

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 and the Novartis announcement.

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

Posted on 10/21/2024

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 and the Astellas Pharma US announcement.

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