Industry News

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

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.
Posted on 11/22/2024

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 and visit the Sandoz website.
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 and the Syndax Pharmaceuticals press release.
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 and visit the Autolus website.
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 and the Novartis 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 and the Astellas Pharma US 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