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.