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Showing 501 - 550Update on Withdrawal of Ibrutinib Accelerated Approvals for MCL and MZL in the United States
AbbVie announced that it intends to voluntarily withdraw, in the United States, accelerated ibrutinib (Imbruvica) approvals for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy as well as patients with marginal zone lymphoma (MZL) who require systemic therapy...
Pragmatica-Lung Trial Begins Enrolling Patients With NSCLC Who Did Not Respond to Previous Therapy
The National Cancer Institute (NCI) announced that it has helped launch the randomized phase III Pragmatica-Lung trial examining the efficacy of ramucirumab plus pembrolizumab in treating patients with advanced non–small cell lung cancer (NSCLC). The new study is one of the first NCI-supported...
Early-Stage Triple-Negative Breast Cancer: Optimizing Therapy
The management of early-stage triple-negative breast cancer has been evolving at a fast pace, thanks largely to the discovery that immune checkpoint blockade can be effective in this subtype. At the 2023 Miami Breast Cancer Conference, Priyanka Sharma, MD, Professor of Medicine, University of...
Highlights of Novel Therapies Under Study in Genitourinary Cancers
Here are some brief reports from the 2023 ASCO Genitourinary (GU) Cancers Symposium that we hope are of interest. They include real-world evidence about the use of avelumab maintenance in metastatic urothelial carcinoma, data on the feasibility of sequencing radium-223 and Lu-177–PSMA-617 in...
Expert Point of View: Oliver Sartor, MD
The results of recent trials of PARP (poly [ADP-ribose] polymerase) inhibitor plus second-generation androgen receptor inhibitor combinations have had varying results in metastatic castration-resistant prostate cancer. Some trials suggest the benefit is confined to those with BRCA mutations and/or...
FDA Grants Accelerated Approval to Enfortumab Vedotin-ejfv/Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
On April 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the antibody-drug conjugate enfortumab vedotin-ejfv (Padcev) in combination with the PD-1 inhibitor pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are...
ELCC 2023: New Data on Amivantamab-vmjw in Patients With Advanced NSCLC and EGFR Exon 20 Insertion Mutations
New long-term data from the CHRYSALIS study evaluating amivantamab-vmjw in patients with advanced non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy were presented by Lopez et al at the 2023 European Lung Cancer...
FDA Grants Full Approval to Pembrolizumab for Certain Adult and Pediatric Patients With Advanced MSI-H or dMMR Solid Tumors
On March 29, the U.S. Food and Drug Administration (FDA) granted full approval to the anti–PD-1 therapy pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors, as...
FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval
On March 24, the U.S. Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is...
Three Models Testing Ways to Lower Drug Costs Outlined in Health and Human Services Report
On February 14, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) selected three models aiming to address high prescription drug costs for testing by the Center for Medicare and Medicaid Innovation (CMMI)....
Expert Point of View: Xin Gao, MD
Xin Gao, MD, Assistant Professor, Harvard Medical School, Genitourinary Cancers Program, Mass General Cancer Center, commented on the results from TROPHY-U-01 cohort 2. “These data add to the overall data on the efficacy of sacituzumab govitecan in patients with metastatic urothelial cancer. This...
I Haven’t Known a Life Without von Hippel-Lindau Disease
Von Hippel-Lindau (VHL) disease has been with me since I was 5 years old, when a benign tumor was found on the optic nerve of my left eye, leaving me blind in that eye. But I didn’t get an official diagnosis of the disease until 2011, when I was 20. By then, it was like a light switch had turned...
Use of Low-Dose Naltrexone
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien (Jason) Hou, PharmD, DiplOM, LAc, and Jyothirmai Gubili, MS, focus...
Carl H. June, MD, FAACR, to Be Honored With 2023 AACR Award for Lifetime Achievement in Cancer Research
The American Associationfor Cancer Research (AACR) will award Carl H. June, MD, FAACR, Fellow of the AACR Academy, with the 2023 AACR Award for Lifetime Achievement in Cancer Research during the 2023 AACR Annual Meeting, April 14–19 in Orlando, Florida. Dr. June is the Richard W. Vague Professor in ...
Walks on a Beach With an Inspiring Grandfather Led to a Career in Cancer Research and Drug Development for Vivek Subbiah, MD
In this installment of The ASCO Post’s Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with Vivek Subbiah, MD, Center Clinical Medical Director of the Clinical Center for Targeted Therapy, Cancer Medicine Division, at The University of Texas MD Anderson Cancer Center, ...
Expert Point of View: Monica Chatwal, MD
Medical oncologist Monica Chatwal, MD, of Moffitt Cancer Center, Tampa, Florida, commented on the take-home points from the ARASENS trial. “The ARASENS trial continues to show a survival benefit for a triplet therapy approach in metastatic hormone-sensitive prostate cancer with androgen-deprivation ...
FDA Grants Accelerated Approval to Retifanlimab-dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
On March 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the PD-1 inhibitor retifanlimab-dlwr (Zynyz) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. PODIUM-201 Safety and efficacy were evaluated in PODIUM-201...
FDA Approves Dabrafenib/Trametinib for Pediatric Patients With BRAF V600E–Mutated Low-Grade Glioma
On March 16, 2023, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) with trametinib (Mekinist) for pediatric patients aged 1 year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both...
FDA Issues Safety Communication on Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants
On March 8, the U.S. Food and Drug Administration (FDA) provided an update on reports of squamous cell carcinoma (SCC) in the scar tissue, or capsule, that forms around breast implants. Previously, on September 8, 2022, the FDA released a safety communication informing the public of reports of...
I’m Doing My Part to Erase the Stigma Surrounding Lung Cancer
Ironically, I received a diagnosis of lung cancer when I was feeling my healthiest. In December 2015, when I was just 51 years old, a routine chest x-ray found a small shadow on the lower lobe of my right lung. Despite being a never-smoker, a regular exerciser, and a healthy eater, my primary care...
FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight
On March 9, the U.S. Food and Drug Administration (FDA) published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities, and help interpreting...
‘Best of SABCS’: Top 7 Picks From the 2022 Meeting by Jame Abraham, MD, FACP
Among the high-quality abstract presentations at the San Antonio Breast Cancer Symposium (SABCS), a few always stand out as particularly meritorious. Each year, The ASCOPost asks our Associate Editor, breast cancer specialist Jame Abraham, MD, FACP, to give us his picks. Dr. Abraham is Chairman of ...
Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
On January 27, 2023, elacestrant was approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine ...
Expert Point of View: David Wang, MD, PhD
David Wang, MD, PhD, Associate Professor of Internal Medicine at UT Southwestern Medical Center and VA North Texas Health Care System, was invited to discuss the CheckMate 649 and RATIONALE 305 studies. “CheckMate 649 was the first randomized controlled trial to demonstrate a significant survival...
Phase III Trials Confirm Benefit of First-Line Anti–PD-1 Inhibition Plus Chemotherapy in Gastric Cancer
Two phase III trials evaluating the addition of drugs targeting PD-1 to chemotherapy—RATIONALE 305 and CheckMate 649—confirmed the benefit of this approach as first-line therapy for advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma, in findings presented at the 2023 ASCO GI...
FDA Expands Early Breast Cancer Indication for Abemaciclib Plus Endocrine Therapy
On March 3, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer at high risk of...
Grateful to Be Alive
Although there is no history of cancer in my family, I guess it isn’t surprising that I would develop an aggressive form of melanoma on my scalp after years of ultraviolet radiation from sun exposure. Still, getting the diagnosis was devastating. I first noticed a small lump on the top of my head ...
Yale Study Indicates Older Patients Are Excluded From Progress Against Lung Cancer
The widespread use of immune checkpoint inhibitors has led to significant benefits in younger patients with advanced lung cancer; however, older patients have not experienced similar survival benefits, according to research from Yale Cancer Center. The study was published in JAMA Oncology.1 “There ...
TALAPRO-2: Talazoparib Plus Enzalutamide Improves Progression-Free Survival in Metastatic Castration-Resistant Prostate Cancer
The TALAPRO-2 phase III clinical trial found that combining the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib with the androgen receptor inhibitor enzalutamide resulted in significantly better progression-free survival vs the current standard of care for patients with metastatic...
MAGNOLIA Trial: Zanubrutinib Yields High Response Rates With Low Rate of Cardiac Events in Marginal Zone Lymphoma
Zanubrutinib—a next-generation Bruton’s tyrosine kinase (BTK) inhibitor—achieved high response rates and durable disease control with a low incidence of cardiac effects in patients with relapsed or refractory marginal zone lymphoma, according to updated findings from the final analysis of the phase ...
Is Zanubrutinib Poised to Become a New Standard of Care in Relapsed or Refractory CLL and SLL?
The next-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib demonstrated superior progression-free survival compared with ibrutinib, with an improved cardiac safety profile, in the first head-to-head comparison between these two BTK inhibitors in relapsed or refractory chronic...
Blinatumomab Improves Survival in MRD-Negative, B-Cell ALL
The standard of care could be changing for adults with newly diagnosed BCR-ABL–negative B-lineage acute lymphoblastic leukemia (ALL) who achieve measurable residual disease (MRD) negativity after induction chemotherapy. In the phase III E1910 trial by the ECOG-ACRIN Cancer Research Group, an...
Highlights From the 2022 ASH Annual Meeting and Exposition
The 2022 American Society of Hematology (ASH) Annual Meeting and Exposition took place in the vibrant city of New Orleans. The meeting brought together tens of thousands of participants from across the world to present and discuss the results of studies that ranged from hypothesis-generating to...
Recent FDA Approvals for Patients With Breast Cancer
On this episode, we’re reviewing two recent U.S. Food and Drug Administration (FDA) approvals for patients with breast cancer: the February 3 approval of sacituzumab govitecan-hziy, and the January 27 approval of elacestrant.
FDA Grants Regular Approval to Dostarlimab-gxly for dMMR Endometrial Cancer
On February 9, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR), recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease has progressed on or...
Influence of the ‘Mark Cuban Effect’ on Cancer Drug Prices in the United States: Focus on CML
The advent of the BCR::ABL1 tyrosine kinase inhibitors for the treatment of Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) was a therapeutic miracle that changed the management paradigm of CML. The first of them, imatinib, was developed in the late 1990s.1,2 Within a few...
Carl H. June, MD, Honored With 2023 AACR Award for Lifetime Achievement in Cancer Research
The American Association for Cancer Research (AACR) will award Carl H. June, MD, with the 2023 AACR Award for Lifetime Achievement in Cancer Research during the AACR Annual Meeting 2023, taking place from April 14 to 19 in Orlando, Florida. Dr. June is the Richard W. Vague Professor in...
FDA Approves Sacituzumab Govitecan-hziy for Pretreated Patients With HR-Positive, HER2-Negative Breast Cancer
On February 3, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable, locally advanced or metastatic, hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ...
Uptake of Immune Checkpoint Inhibitors and Survival Among Younger and Older Patients With Advanced NSCLC
In a U.S. cohort study reported in JAMA Oncology, Voruganti et al found that the uptake of immune checkpoint inhibitor therapy for patients with advanced non–small cell lung cancer (NSCLC) has been associated with “modest” improvements in overall survival, particularly among older patients. As...
FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
On January 27, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BRUIN Efficacy was...
FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
On January 27, the U.S. Food and Drug Administration (FDA) approved elacestrant (Orserdu) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine...
FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC
On January 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage IB (T2a, ≥ 4 cm), II, or IIIA non–small cell lung cancer (NSCLC). KEYNOTE-091 Efficacy was evaluated in...
FDA Oncology Center of Excellence Seeks Applications for New Research Funding Opportunities
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott...
MAGNOLIA Trial: Zanubrutinib Yields High Response Rates With Low Rate of Cardiac Events in Marginal Zone Lymphoma
Zanubrutinib—a next-generation Bruton’s tyrosine kinase (BTK) inhibitor—achieved high response rates and durable disease control with a low incidence of cardiac effects in patients with relapsed or refractory marginal zone lymphoma, according to updated findings from the final analysis of the phase ...
FDA Approves Zanubrutinib for CLL or SLL
On January 19, the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor zanubrutinib (Brukinsa) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). SEQUOIA Trial: Treatment-Naive Patients Efficacy in treatment-naive patients...
Is Zanubrutinib Poised to Become a New Standard of Care in Relapsed or Refractory CLL and SLL?
The next-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib demonstrated superior progression-free survival compared with ibrutinib, with an improved cardiac safety profile, in the first head-to-head comparison between these two BTK inhibitors in relapsed or refractory chronic...
FDA Grants Accelerated Approval to Tucatinib Plus Trastuzumab for Advanced HER2-Positive Colorectal Cancer
On January 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor tucatinib (Tukysa) in combination with the monoclonal antibody trastuzumab for RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following...
Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
On October 21, 2022, tremelimu-mab-actl was approved by the U.S. Food and Drug Administration (FDA) for use in combination with durvalumab in the treatment of unresectable hepatocellular carcinoma.1 Supporting Efficacy Data Approval was based on a comparison of overall survival in the...
Blinatumomab Improves Survival in MRD-Negative, B-Cell ALL
The standard of care could be changing for adults with newly diagnosed BCR-ABL–negative B-lineage acute lymphoblastic leukemia (ALL) who achieve measurable residual disease (MRD) negativity after induction chemotherapy. In the phase III E1910 trial by the ECOG-ACRIN Cancer Research Group, an...
