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.

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