INDUSTRY NEWS
Industry News
FDA Approves Imlunestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer
September 26, 2025
The FDA approved imlunestrant for select adults with estrogen receptor-positive, human epidermal growth factor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer.
For more information read the FDA announcement and Eli Lilly and Company press release.
FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection
September 24, 2025
The FDA approved pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab.
For more information read the FDA announcement and Merck press release.
FDA Approves Selumetinib for Select Pediatric Patients 1 Year of Age and Older
September 11, 2025
The FDA approved selumetinib granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
For more information read the FDA announcement and Koselugo website.
FDA Approves Gemcitabine Intravesical System for Non-muscle Invasive Bladder Cancer
September 11, 2025
The FDA approved gemcitabine intravesical system for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
For more information read the FDA announcement and Janssen Biotech press release.
FDA Grants Accelerated Approval to Zongertinib for Non-Squamous NSCLC With HER2 TKD Activating Mutations
August 18, 2025
The FDA granted accelerated approval to zongertinib for select adults with unresectable or metastatic non-squamous non-small cell lung cancer.
For more information read the FDA announcement and Boehringer Ingelheim Pharmaceuticals press release.
FDA Grants Accelerated Approval to Dordaviprone for Diffuse Midline Glioma
August 8, 2025
The FDA granted accelerated approval to dordaviprone for select patients with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
For more information read the FDA announcement and Jazz Pharmaceuticals press release.
FDA Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs Within Bristol Myers Squibb’s Cell Therapy Labels
July 7, 2025
The FDA approved label updates for both of Bristol Myers Squibb's CAR T-cell therapies: lisocabtagene maraleucel and idecabtagene vicleucel.
For more information read the Bristol Myers Squibb press release.
FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non-Small Cell Lung Cancer
July 7, 2025
The FDA granted accelerated approval to sunvozertinib for select adult patients with locally advanced or metastatic non-small cell lung cancer.
For more information read the FDA announcement and Dizal (Jiangsu) Pharmaceutical website.
FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma
July 2, 2025
The FDA granted accelerated approval to linvoseltamab-gcpt for select adults with relapsed or refractory multiple myeloma.
For more information read the FDA announcement and Regeneron Pharmaceuticals press release.
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.
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