Industry News

FDA Approves Lutetium Lu 177 Dotatate for Pediatric Patients with Astroenteropancreatic Neuroendocrine Tumors

On April 23, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
For more information read the FDA announcement.
Posted 4/24/2024

FDA Approves Nogapendekin Alfa Inbakicept-pmln for Invasive Bladder Cancer

On April 22, the US Food and Drug Administration approved nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
For more information read the FDA announcement.
Posted 4/23/2024

FDA Approves Alectinib for ALK-positive Non-Small Cell Lung Cancer

On April 18, the US Food and Drug Administration (FDA) approved alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test.
For more information read the FDA announcement and the Genentech Inc. announcement.
Posted 4/18/2024

FDA Approves Fam-trastuzumab deruxtecan-nxki for Unresectable or Metastatic HER2-positive Solid Tumors

On April 5, the US Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
For more information read the FDA announcement.
Posted 4/8/2024

FDA Approves Mirvetuximab Soravtansine-gynx for Certain Ovarian Cancers

On March 22, the US Food and Drug Administration (FDA) approved mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens.
For more information read the FDA announcement and the AbbVie announcement.
Posted 3/25/2024

FDA Approves Oral Suspension Ibrutinib in Adults with Chronic Lymphocytic Leukemia & Small Lymphocytic Lymphoma

On February 24, the US Food and Drug Administration (FDA) approved a label expansion for ibrutinib with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Ibrutinib is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation.
For more information read the Johnson & Johnson announcement.
Posted 3/21/2024

FDA Approves Ponatinib + Chemotherapy for Lymphoblastic Leukemia

On March 19, the US Food and Drug Administration (FDA) granted accelerated approval to ponatinib in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
For more information read the FDA announcement and the Takeda Pharmaceuticals announcement.
Posted 3/20/2024

FDA Approves Tislelizumabjsgr for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

On March 14, the US Food and Drug Administration (FDA) approved tislelizumabjsgr as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
For more information read the BeiGene announcement.
Posted 3/15/2024

Changes to Ropeginterferon alfa-2b-njft in Updated NCCN Clinical Practice Guidelines

On February 27, PharmaEssentia, announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have recently been updated to include ropeginterferon alfa-2b-njft, marketed as BESREMi®, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk polycythemia vera.
For more information read the PharmaEssentia announcement.
Posted 3/13/2024