INDUSTRY NEWS
Industry News
FDA Grants Accelerated Approval to Datopotamab Deruxtecan-dlnk for EGFR-Mutated Non-Small Cell Lung Cancer
June 25, 2025
The FDA granted accelerated approval to datopotamab deruxtecan-dlnk for select adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.
For more information read the FDA announcement and Daiichi Sankyo website .
FDA Approves Tafasitamab-cxix for Relapsed or Refractory Follicular Lymphoma
June 25, 2025
The FDA approved tafasitamab-cxix with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
For more information read the FDA announcement and Incyte Corporation press release .
FDA Approves Neoadjuvant and Adjuvant Pembrolizumab for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
June 17, 2025
The FDA approved pembrolizumab for select adults with resectable locally advanced head and neck squamous cell carcinoma.
For more information read the FDA announcement and Merck press release .
FDA Approves Mitomycin Intravesical Solution for Recurrent Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
June 12, 2025
The FDA approved mitomycin intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
For more information read the FDA announcement and UroGen Pharma website .
FDA Approves Tablet Formulation of Zanubrutinib for All Approved Indications
June 12, 2025
The FDA approved a new tablet formulation of zanubrutinib for all 5 approved indications.
For more information read the BeOne Medicines website .
FDA Approves Taletrectinib for ROS1-positive Non-small Cell Lung Cancer
June 12, 2025
The FDA approved taletrectinib a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
For more information read the FDA announcement and Nuvation Bio press release .
FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
June 3, 2025
The FDA approved darolutamide for metastatic castration-sensitive prostate cancer.
For more information read the FDA announcement and Bayer Healthcare Pharmaceuticals Inc press release .
FDA Approves Retifanlimab-dlwr With Carboplatin and Paclitaxel and as a Single Agent for Squamous Cell Carcinoma of the Anal Canal
May 16, 2025
The FDA recently approved retifanlimab-dlwr with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.
For more information read the FDA announcement and Incyte Corporation press release .
FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC With High c-Met Protein Overexpression
May 16, 2025
The FDA granted accelerated approval to telisotuzumab vedotin-tllv a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy.
For more information read the FDA announcement and AbbVie Inc. press release. .
FDA Approves Belzutifan for Pheochromocytoma or Paraganglioma
May 16, 2025
The FDA recently approved belzutifan for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.
For more information read the FDA announcement and Merck & Co., Inc. press release .
FDA Grants Accelerated Approval to the Combination of Avutometinib and Defactinib for Select Patients With Ovarian Cancer
May 9, 2025
The FDA granted accelerated approval to the combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.
For more information read the FDA announcement and Verastem press release .
FDA Approves Penpulimab-kcqx for Non-Keratinizing Nasopharyngeal Carcinoma
April 24, 2025
FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma and as a single agent for adults with metastatic non-keratinizing NPC.
For more information read the FDA announcement .
FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma
April 11, 2025
The FDA approved nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
For more information read the FDA announcement and Bristol Myers Squibb press release .
FDA Approves Larotrectinib for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors
April 11, 2025
The FDA granted full approval for larotrectinib, a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion.
For more information read the Bayer press release .
FDA Expands Pluvicto’s Metastatic Castration-Resistant Prostate Cancer Indication
April 8, 2025
The FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan to include adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.
For more information read the and FDA announcement and Novartis press release .
FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
April 8, 2025
The FDA approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic colorectal cancer.
For more information read the FDA announcement .
FDA Approves Durvalumab for Muscle-Invasive Bladder Cancer
March 28, 2025
The FDA approved durvalumab, combined with gemcitabine and cisplatin neoadjuvant treatment in muscle-invasive bladder cancer.
For more information read the FDA announcement .
FDA Approves Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
March 26, 2025
The FDA approved cabozantinib for the treatment of well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.
For more information read the FDA announcement and Exelixis press release .
FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1
March 19, 2025
The US Food and Drug Administration (FDA) granted traditional approval to pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy.
For more information read the FDA announcement .
Geron Announces European Commission Approval of Imetelstat for the Treatment of Adults With Transfusion-Dependent Anemia
March 13, 2025
The European Commission (EC) granted marketing authorization for imetelstat (RYTELO®) as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low, or intermediate-risk myelodysplastic syndromes
For more information read the Geron press release .
FDA Approves Tislelizumab-jsgr for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination With Chemotherapy
March 12, 2025
On March 4, the US Food and Drug Administration (FDA) approved TEVIMBRA® (tislelizumab-jsgr) in combination with platinum-containing chemotherapy.
For more information read the Beigene press release .
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic HR-positive, HER2-low or HER2-ultralow Breast Cancer
February 20, 2025
The US Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki, Enhertu for unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer
For more information read the FDA announcement and Daiichi Sankyo press release. .
FDA Approves Vimseltinib for Symptomatic Tenosynovial Giant Cell Tumor
February 17, 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor.
For more information read the FDA announcement and Deciphera press release .
FDA Approves Mirdametinib for Select Adult and Pediatric Patients With Neurofibromatosis Type 1
February 12, 2025
The FDA approved mirdametinib for adults and children aged 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that cannot be completely resected.
For more information read the FDA announcement and SpringWorks Therapeutics press release .
FDA Approves Brentuximab Vedotin With Lenalidomide and Rituximab for Relapsed or Refractory Large B-Cell Lymphoma
February 12, 2025
FDA has approved brentuximab vedotin plus lenalidomide and rituximab for adults with relapsed or refractory large B-cell lymphoma.
For more information read the FDA announcement and Pfizer press release .
FDA Approves Treosulfan With Fludarabine as a Preparative Regimen for alloHSCT in Adult and Pediatric Patients with AML or MDS
February 7, 2025
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS.
For more information read the FDA Announcement and Medexus press release. .
Patients New to Nubeqa Will be Subject to New Prior Authorization Criteria
February 4, 2025
Patients with Aetna® Medicare Advantage or SilverScript® coverage who have metastatic hormone-sensitive prostate cancer (mHSPC) and are new to NUBEQA® are subject to new prior authorization (PA) criteria.
For more information read the Bayer Access Services .
FDA Approves Datopotamab Deruxtecan-dlnk for Unresectable or Metastatic, HR-positive, HER2-Negative Breast Cancer
January 28, 2025
The FDA approved datopotamab deruxtecan-dlnk for adult patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
For more information read the FDA announcement and AstraZeneca press release .
FDA Safety Announcement on the Importance of DPD Deficiency Discussions With Patients Before Capecitabine or 5FU Treatment
January 28, 2025
The FDA released new information to increase awareness of recent updates to capecitabine and fluorouracil product labeling.
For more information read the FDA announcement .
FDA Approves Sotorasib With Panitumumab for KRAS G12C-Mutated Colorectal Cancer
January 17, 2025
The FDA approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
For more information read the FDA announcement and Amgen press release .
FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma
January 17, 2025
The FDA granted traditional approval to acalabrutinib with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.
For more information read the FDA announcement and AstraZeneca press release .
FDA Approves Encorafenib Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
January 13, 2025
The FDA approved encorafenib in combination with cetuximab and fluorouracil, leucovorin, and oxaliplatin for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
For more information read the Pfizer press release .
FDA Approves Tislelizumab-jsgr for First-line Treatment of Gastric and Gastroesophageal Junction Cancers
January 2, 2025
The FDA recently approved tislelizumab-jsgr in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
For more information read the BeiGene press release .
FDA Approves Nivolumab and Hyaluronidase-nvhy for Subcutaneous Injection
January 2, 2025
The FDA recently approved nivolumab and hyaluronidase-nvhy for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib.
For more information read the FDA announcement and Bristol Myers Squibb press release .
FDA Approves Blinatumomab for 72- and 96-Hour Infusion Durations
December 23, 2024
The FDA approved blinatumomab for 72- and 96-hour infusion durations to offer more flexibility for physicians and their patients.
For more information read the BLINCYTO website .
FDA Grants Accelerated Approval to Encorafenib With Cetuximab and mFOLFOX6 for Metastatic Colorectal Cancer With a BRAF V600E Mutation
December 23, 2024
The FDA 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 Array BioPharma press release .
FDA Approves Remestemcel-L-rknd for Steroid-Refractory Acute Graft Versus Host Disease in Pediatric Patients
December 23, 2024
The FDA 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 Mesoblast website .
FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
December 23, 2024
The FDA 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 Xcovery Holdings website .
FDA Approves Cosibelimab-ipdl for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
December 23, 2024
The FDA approved cosibelimab-ipdl, a programmed death ligand-1 blocking antibody, for select adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC.
For more information read the FDA announcement and Checkpoint Therapeutics press release .
FDA Approves Durvalumab for Limited-Stage Small Cell Lung Cancer
December 6, 2024
The 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 and AstraZeneca press release .
FDA Grants Accelerated Approval to Zenocutuzumab-zbco for Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma
December 6, 2024
The FDA granted accelerated approval to zenocutuzumab-zbco for select adults.
For more information read the FDA announcement and Merus N.V. press release .
FDA Grants Accelerated Approval to Zanidatamab-hrii for Select Cases of Biliary Tract Cancer
November 22, 2024
Jazz Pharmaceuticals, Inc. recently received FDA accelerated approval for zanidatamab-hrii 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 Jazz Pharmaceuticals press release .
FDA Approves Updated Drug Labeling for Fludarabine phosphate Under Project Renewal
November 20, 2024
The 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 Sandoz website .
FDA Approves Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation
November 20, 2024
The FDA recently 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 Syndax Pharmaceuticals press release .
FDA Approves Obecabtagene autoleucel for Adults With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
November 14, 2024
Obecabtagene autoleucel, a CD19-directed genetically modified autologous T cell immunotherapy, received FDA approval for select adults with acute lymphoblastic leukemia.
For more information read the FDA announcement and Autolus website .
Anemia in Focus: The Challenge of Identifying Myelodysplastic Syndromes (MDS)
November 9, 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.
For more information read the View Resource .
FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia
October 29, 2024
The 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 Novartis announcement .
New Insurance Codes for Scalp Cooling Will Transform Access for Cancer Patients
October 24, 2024
The American Medical Association introduced new Category I CPT 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 .
FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer
October 24, 2024
The FDA recently 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 .
FDA Approves Zolbetuximab-clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma
October 21, 2024
The 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 Astellas Pharma US announcement .