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Showing 51 - 100FDA Grants Traditional Approval to Pirtobrutinib for CLL/SLL
On December 3, the U.S. Food and Drug Administration (FDA) granted traditional approval to pirtobrutinib (Jaypirca), a noncovalent Bruton’s tyrosine kinase (BTK) inhibitor, for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have...
FDA Approves Durvalumab With FLOT for Resectable Gastric/GEJ Adenocarcinoma
On November 25, 2025, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single-agent durvalumab, for the treatment of adult...
New Approvals in Hematologic Malignancies, Skin Cancer, and Small Cell Lung Cancer
Here are brief reports on four oncology approvals by the U.S. Food and Drug Administration (FDA) in October 2025: • Menin Inhibitor in NPM1-Positive AML : On October 24, 2025, the FDA approved revumenib (Revuforj), a menin inhibitor, for the treatment of relapsed or refractory acute myeloid...
Memorial Sloan Kettering Names Recipients of 2025 Paul Marks Prize for Cancer Research
Memorial Sloan Kettering Cancer Center (MSK) will award three cancer researchers with this year’s Paul Marks Prize for Cancer Research. The prize, named in honor of former MSK president Paul Marks, MD, recognizes a new generation of leaders who are making significant contributions to the...
FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle-Invasive Bladder Cancer
On November 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) or the subcutaneous formulation pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant treatment followed by adjuvant treatment...
Large AI Breast Cancer Screening Trial Increases Detection Rate by 20%
Using an artificial intelligence (AI)–integrated workflow, DeepHealth, in computer-aided detection of breast cancer from digital breast tomosynthesis exams found 21.6% more cases than the usual standard of care, according to findings from the AI-Supported Safeguard Review Evaluation (ASSURE) study...
Reducing the Barriers to Receiving CAR T-Cell Therapy for Patients With Hematologic Malignancies
Chimeric antigen receptor (CAR) T-cell therapy has transformed treatment for patients with hematologic malignancies, achieving unprecedented responses in some patients, especially those diagnosed with relapsed/refractory B-cell acute lymphocytic leukemia, non-Hodgkin lymphoma, and multiple...
Traditional Approval Granted to Tarlatamab-dlle for Extensive-Stage SCLC
On November 19, the U.S. Food and Drug Administration (FDA) granted traditional approval to tarlatamab-dlle (Imdelltra), a DLL3-targeting bispecific T-cell engager, for adults with extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy....
FDA Grants Accelerated Approval to Sevabertinib for Nonsquamous NSCLC
On November 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adults with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD) activating...
Newly Diagnosed AL Amyloidosis: FDA Grants Traditional Approval to Regimen
On November 19, the U.S. Food and Drug Administration (FDA) granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. The FDA granted accelerated approval to the...
FDA Approves Selumetinib for Adults With NF1 With Symptomatic, Inoperable Plexiform Neurofibromas
On November 19, the U.S. Food and Drug Administration (FDA) approved selumetinib (Koselugo), a MEK inhibitor, for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). In September 2025, the FDA approved selumetinib capsules and granules for...
FDA Approves Epcoritamab for Two Follicular Lymphoma Indications
On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp (Epkinly), a bispecific CD20-directed CD3 T-cell engager, in combination with lenalidomide and rituximab for the treatment of patients with relapsed or refractory follicular lymphoma. In addition, the FDA...
Sacituzumab Tirumotecan Improves Survival in EGFR-Mutated NSCLC After Tyrosine Kinase Inhibitor Failure
Sacituzumab tirumotecan, a novel TROP2 antibody-drug conjugate, was found to significantly improve both progression-free and overall survival compared with platinum-based chemotherapy in patients with EGFR-mutated non–small cell lung cancer (NSCLC) who had experienced disease progression following...
FDA Approves New Interchangeable Biosimilar to Pertuzumab
The U.S. Food and Drug Administration (FDA) has approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta). This is the first approval of a biosimilar for pertuzumab. Pertuzumab-dpzb is a HER2/neu receptor antagonist indicated for the following: Use in combination...
FDA Approves Ziftomenib for NPM1-Positive AML
On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved ziftomenib (Komzifti), a menin inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options...
Longtime FDA Innovator Appointed as Director of CDER
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced that Richard Pazdur, MD, has been appointed Director of the Center for Drug Evaluation and Research (CDER). Dr. Pazdur is a 26-year veteran of the FDA and the Founding Director of its...
FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma. Efficacy of daratumumab and hyaluronidase as monotherapy vs active monitoring was evaluated in AQUILA, an open-label,...
Raajit K. Rampal, MD, PhD, on JAK Inhibitors—And Beyond!
Raajit K. Rampal, MD, PhD, Director of the Center for Hematologic Malignancies and the Myeloproliferative Neoplasms Program at Memorial Sloan Kettering Cancer Center, reviews the four FDA-approved Janus kinase (JAK) inhibitors for patients with myelofibrosis, touching upon differences in their...
Zenocutuzumab Potential Explored in NRG1-Positive Cholangiocarcinoma
Zenocutuzumab-zbco yielded clinical activity in more than one-third of patients with cholangiocarcinoma and an NRG1 fusion, according to findings from the phase II eNRGy trial presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Abstract ...
Revumenib Approved by FDA for NPM1-Positive AML
On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved revumenib (Revuforj), a menin inhibitor, for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation, in adult and pediatric patients 1 year and older who have no...
FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma
On October 23, 2025, the U.S. Food and Drug Administration (FDA) approved belantamab mafodotin-blmf (Blenrep), a B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate, in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or...
New Approvals in Breast and Bladder Cancers
Here are brief reports on three oncology approvals by the U.S. Food and Drug Administration (FDA) in September 2025: • Estrogen Receptor Antagonist in Advanced or Metastatic Breast Cancer: The FDA has approved imlunestrant (Inluriyo), an estrogen receptor antagonist, for adults with estrogen...
Reversible TKI in HER2-Mutant NSCLC
The oral targeted therapy sevabertinib led to tumor reduction and manageable side effects in patients with HER2-mutant non–small cell lung cancer (NSCLC), according to data from the phase I/II SOHO-01 clinical trial. Over 70% of the patients studied saw their tumors shrink or disappear. The results ...
Belzutifan Achieves Durable Responses Without Surgery in Advanced Pheochromocytoma/Paraganglioma
Belzutifan induced durable responses without surgery in patients with advanced pheochromocytoma or paraganglioma and demonstrated manageable safety in the phase II LITESPARK-015 trial, according to findings presented during the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract...
VT3989 Demonstrates Antitumor Activity and Tolerability in Refractory Mesothelioma
The first-in-class YAP-TEAD inhibitor VT3989 has demonstrated promising antitumor activity and tolerability in patients with refractory mesothelioma, according to findings from a phase I/II trial presented at the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract 920O) and...
Lisaftoclax Regimens Effective in Plasma Cell Disorders
Lisaftoclax, an investigational BCL2 inhibitor, in combination with pomalidomide/dexamethasone (Pd) or daratumumab/lenalidomide/dexamethasone (DRd) led to improved outcomes for patients with relapsed or refractory multiple myeloma and for patients with AL amyloidosis, according to findings from a...
EHA Publishes Guidelines for LBCL and Multiple Myeloma
The European Hematology Association (EHA) has published two new sets of clinical practice guidelines, including its first dedicated guidelines for large B-cell lymphoma (LBCL), which was published in HemaSphere, as well as an updated set of guidelines in collaboration with the European Myeloma...
PD-1 Inhibitor Approved for Adjuvant Treatment of CSCC
On October 8, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation therapy. C-POST Efficacy was evaluated in C-POST (ClinicalTrials.gov ...
FDA Approves Combination Regimen for Extensive-Stage SCLC
On October 2, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for maintenance treatment of adults with extensive-stage small cell lung cancer (SCLC) whose disease...
Prostate Cancer: Radiopharmaceutical Plus SBRT Delays Progression in Patients With Limited Metastatic Disease
A new clinical trial found that people with a limited number of metastases from recurrent prostate cancer lived significantly longer without disease progression when they received a radiopharmaceutical drug before targeted radiation compared with radiation alone. The phase II LUNAR trial is the...
FDA Removes Vandetanib REMS Program
On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency. Vandetanib is a tyrosine kinase inhibitor targeting VEGFR, EGFR, and RET from manufacturer Sanofi (formerly ...
Advanced or Metastatic Breast Cancer: FDA Approves Imlunestrant for ER-Positive, HER2-Negative, ESR1-Mutated Disease
The U.S. Food and Drug Administration (FDA) has approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, HER2-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression after at least one line of...
HPV Self-Sampling Collection Test Improved Cervical Cancer Screening Rates Among Asian American Women
Studies have shown that human papillomavirus (HPV) infection—especially with high-risk variants such as HPV16 and HPV18—is the primary cause of cervical cancer, accounting for about 95% of all cases. Although cervical cancer screening through Pap smear tests can detect the presence of precancerous...
AACR Cancer Progress Report 2025 Highlights Breakthroughs in Blood Cancers and How NIH Funding Uncertainty Threatens Advances
The 15th edition of the annual AACR Cancer Progress Report presents a mixed picture of the major advances in cancer care over the past year, including the approval of 20 new anticancer drugs, juxtaposed against the continuing rise in early-onset cancers and disparities in care as well as the...
FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection
The U.S. Food and Drug Administration (FDA) approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda). Efficacy and...
New Approvals for Thrombocytopenia, Lung Cancer, Brain Cancer, and Multiple Myeloma
BTK Inhibitor for Chronic Immune Thrombocytopenia: On September 2, 2025, the U.S. Food and Drug Administration (FDA) approved the Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib (Wayrilz) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an...
Contemporary Management of Chronic Myeloid Leukemia, According to Hagop M. Kantarjian, MD, FASCO
Chronic myeloid leukemia (CML) is one of the success stories among the hematologic malignancies. Now, with decades of data informing its management, it is time to change some of the practices to which clinicians have become accustomed, said leukemia expert Hagop M. Kantarjian, MD, FASCO, Professor...
New Subcutaneous Amivantamab Combo Dosing Schedule Shows Promising Safety and Efficacy in EGFR-Positive NSCLC
The combination of subcutaneous amivantamab-vmjw every 4 weeks plus daily oral lazertinib led to a high response rate in patients with previously untreated EGFR-mutated advanced non–small cell lung cancer (NSCLC), according to findings from an analysis of cohort 5 of the PALOMA-2 trial presented at ...
FDA Approves Kinase Inhibitor for Pediatric Patients With NF1
The U.S. Food and Drug Administration (FDA) has approved selumetinib (Koselugo) granules and capsules for pediatric patients aged 1 year and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA previously approved selumetinib capsules for...
FDA Approves Gemcitabine Intravesical System for Non–Muscle-Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has approved the gemcitabine intravesical system (Inlexzo) for adults with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. The gemcitabine intravesical system is...
FDA’s OCE Invites External Research Questions to Advance Science, Benefit Patients
The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) invites academic and patient advocate researchers to propose research questions for Project Collaborate, a unique crowdsourcing initiative running through September 26. This represents a rare opportunity to leverage...
Observation Outperforms Adjuvant Crizotinib for Resected ALK-Positive NSCLC
Adjuvant treatment with the first-generation ALK inhibitor crizotinib failed to improve disease-free survival outcomes over observation for patients with surgically resected ALK-positive non–small cell lung cancer (NSCLC), according to findings from the phase III E4512 trial presented at the...
FDA Approves BTK Inhibitor for ITP
The U.S. Food and Drug Administration (FDA) has approved rilzabrutinib (Wayrilz), a Bruton’s tyrosine kinase (BTK) inhibitor, for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA ...
Understanding Accelerated Aging in Survivors of Childhood Cancers
Each year in the United States, nearly 16,000 children and adolescents between the ages of birth and 19 are diagnosed with cancer.1 And although survival rates have greatly improved for many types of childhood cancers, with more than 8 in 10 children and adolescents surviving at least 5 years after ...
Smoldering Multiple Myeloma: How the Guidance Is Changing
Clinical trials have sought to determine the benefit of treating the precursors of multiple myeloma, but as the phenotypes and genomics of this entity are becoming better delineated, the wisdom of early intervention has remained confusing for clinicians. At the 2025 Debates and Didactics in...
Treatment Rechallenge After Interstitial Lung Disease Related to T-DXd: Is It Safe?
Rechallenge with the HER2-directed antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) after grade 1 interstitial lung disease (ILD) appeared to be safe in a diverse real-world population, including many patients with breast cancer, as presented during the 2025 ASCO Annual Meeting.1 The ...
New Report Supports Overhaul of Cancer Drug Dosing
A new study calls for a paradigm shift in how cancer drug dosages are determined, concluding that the long-standing practice of using the “maximum tolerated dose” (MTD) may be outdated, harmful to patients, and ill-suited for modern cancer therapies. “The Totality of the Evidence: Optimizing Dosage ...
Emerging PD-1 Inhibitor Plus Chemotherapy Shows Efficacy in Second-Line Classical Hodgkin Lymphoma
The addition of the PD-1 inhibitor sintilimab to ICE (ifosfamide, carboplatin, and etoposide) chemotherapy appeared to significantly improve the complete remission rate and showed a trend toward improved progression-free survival in second-line classical Hodgkin lymphoma, according to Yuankai Shi,...
Are Postmastectomy Implant-Based Breast Reconstructions Associated With Lymphomas of the Breast?
The results of a cohort study published in JAMA Network Open revealed an epidemiologic association between postmastectomy implant-based breast reconstruction for any breast tumor and both B- and T-cell non-Hodgkin lymphomas of the breast. According to Kinslow et al, this includes diffuse large...
Kinase Inhibitor Approved for Nonsquamous NSCLC With HER2 TKD–Activating Mutations
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD)–activating mutations, as...
