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Showing 51 - 100Pirtobrutinib Improves Progression-Free Survival vs Bendamustine/Rituximab in Front-Line CLL/SLL
The first prospective, randomized phase III trial of a noncovalent Bruton’s tyrosine kinase (BTK) inhibitor exclusively in treatment-naive patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)—BRUIN CLL-313—demonstrated a statistically significant and clinically...
Multiple Myeloma: FDA Approves Daratumumab and Hyaluronidase-fihj in Combination With VRd
On January 27, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous...
Evolving Treatment Landscape Spurs Living Guideline Update on Multiple Myeloma
ASCO, in collaboration with Ontario Health (Cancer Care Ontario), has published an update to their previous guideline on the treatment of multiple myeloma.1 This new guideline—which has been selected as an ASCO Living Guideline—reflects dramatic changes that have helped improve the management of...
FDA Releases Draft Guidance for Use of MRD and CR as Primary Endpoints in Multiple Myeloma Trials
On January 20, 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry regarding the use of minimal residual disease and complete response as primary endpoints in clinical trials evaluating drugs and biologics for the treatment of patients with multiple myeloma that ...
Popular Supplement May Interfere With Cancer Treatment
For many patients with cancer, hair loss can be one of the most distressing side effects of their therapy. Increasingly, patients have been taking oral supplements of biotin, which are marketed to consumers for their potential to improve hair regrowth and brittle nails. However, there is little...
Regulatory Agencies Establish Principles of Good AI Use in Drug Development
The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have collaborated with the European Medicines Agency (EMA) to develop a set of 10 guiding principles for good uses of artificial intelligence (AI) in...
FDA Increases Flexibility on Requirements for Cell and Gene Therapies
The U.S. Food and Drug Administration (FDA) has announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGTs). The agency’s more flexible approach has been, and is expected to...
MajesTEC-3: ‘Unprecedented’ Benefit in Previously Treated Multiple Myeloma
For patients with previously treated multiple myeloma, the greatest risk reduction yet achieved in a phase III clinical trial was reported with the BCMA-directed CD3 T-cell engager teclistamab-cqyv plus daratumumab and hyaluronidase-fihj. Treatment with this combination resulted in an 83% reduction ...
FDA Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection
On December 17, the U.S. Food and Drug Administration (FDA) approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant). PALOMA-3 The subcutaneous injection of ...
FDA Grants Regular Approval to Rucaparib for Metastatic Castration-Resistant Prostate Cancer
On December 17, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor rucaparib (Rubraca) for adults with deleterious BRCA mutation (germline and/or somatic)–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor–directed therapy....
Intravesical Cretostimogene Grenadenorepvec Shows Strong High-Grade Recurrence-Free Survival in BCG-Unresponsive Papillary-Only Non–Muscle-Invasive Bladder Cancer
Intravesical cretostimogene grenadenorepvec (CG0070) monotherapy demonstrated strong high-grade recurrence-free survival rates in patients with high-risk, papillary-only, bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer, according to data presented at the 26th Annual...
Flipped Nivolumab/Ipilimumab Dosing Improves Responses, Survival, and Safety in Advanced Melanoma
The flipped dose for nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg led to improved response rates and survival findings as well as lower severe immune-related toxicities compared with the standard dose of the immunotherapy combination in patients with advanced unresectable melanoma, according to...
HER2-Positive Breast Cancer: FDA Approves T-DXd Plus Pertuzumab
On December 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved...
FDA Approves Regimen for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer
On December 12, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor niraparib and the hormone therapy abiraterone acetate (Akeega) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by ...
AI Tops Density in Predicting Breast Cancer Risk
An image-only artificial intelligence (AI) model for predicting the 5-year risk of breast cancer provided stronger and more precise risk stratification than breast density assessment, according to a news statement issued about a study presented at the annual meeting of the Radiological Society of...
Ironically, Smoking May Have Saved My Life
I was diagnosed with stage IV non-small cell lung (NSCLC) adenocarcinoma on August 1, 2013—World Lung Cancer Day. If it hadn’t been for an article that caught my eye the year before about the recommendation from the United States Preventive Services Task Force that all men aged 65 to 75 who have...
ASCO Statement: HHS Revision of Black Box Warning for Hormone Replacement Therapy and its Implications for Cancer Care
On November 10, 2025, the Department of Health and Human Services announced that the Food and Drug Administration will begin to remove the “black box” warning language related to increased risks of cardiovascular disease, breast cancer, and probable dementia from hormone replacement therapy (HRT)...
Mount Sinai Tisch Cancer Center Receives Comprehensive Cancer Center Designation and Funding from National Cancer Institute
The Mount Sinai Tisch Cancer Center (TCC) has been named a Comprehensive Cancer Center by the National Cancer Institute (NCI), the highest designation awarded to cancer centers in the United States. This recognition places Mount Sinai among the top one percent of cancer centers nationwide and...
Research Supports FDA Approval of Sevabertinib for HER2-Mutant Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved sevabertinib, an oral targeted therapy, for adult patients with non-small-cell lung cancer (NSCLC) whose tumors harbor certain HER2 (ERBB2) mutations and who have previously received chemotherapy or immunotherapy. The approval reflects a...
New FDA-Approved Oncology Drugs and Label Updates Between December 1, 2024, and November 19, 2025
Over the past year (December 2024–November 19, 2025), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers. The new approvals and accelerated approvals are listed below according to the most recent new...
New Pooled Analysis Strengthens Case for MRD as Surrogate Endpoint in AML
Measurable residual disease (MRD), regardless of the method of assessment, is a robust individual-level predictor for overall survival among patients with acute myeloid leukemia (AML) who have already received induction therapy, according to findings from a pooled analysis presented at the 2025...
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 CAR T-Cell Therapy for Relapsed/Refractory Marginal Zone Lymphoma
On December 4, 2025, the U.S. Food and Drug Administration (FDA) approved the CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior...
ASCO Statement on the Departure of Richard Pazdur, MD, From the FDA
Richard Pazdur, MD, Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA) and former long-time head of the FDA Oncology Center of Excellence (OCE), is leaving the FDA. Dr. Pazdur has served the FDA for 26 years and is an expert in drug regulation....
Upfront Reduced-Dose Enfortumab Vedotin With Pembrolizumab in First-Line Treatment of Advanced Urothelial Cancer
In a U.S. retrospective cohort study reported in JAMA Oncology, Chow et al found that reduced-dose vs standard upfront enfortumab vedotin-ejfv plus pembrolizumab reduced the risk of enfortumab vedotin treatment interruption in the first-line treatment of patients with advanced urothelial cancer....
FDA 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...
