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Showing 951 - 1000FDA Pipeline: Bemarituzumab Granted Breakthrough Therapy Designation for FGFR2b-Overexpressing, HER2-Negative Gastric Cancer
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b)-overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma...
Nivolumab/Ipilimumab Plus Two Cycles of Histology-Based Chemotherapy: Another Option in First-Line Metastatic NSCLC
Introduction of immunotherapy has revealed a paradigm shift in the management of patients with metastatic non–small cell lung cancer (NSCLC) that does not harbor a therapeutically targetable driver mutation. Over the past 5 years, several trials have informed treatment decisions, based on disease...
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Endometrial Cancer
On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior...
To Advance Health Equity, Put Real-World Cancer Data to Work
Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons—like institutional racism and poverty—are a reflection of our broader society. Other inequities may go unrecognized but are no less damaging. People with underlying health...
FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More
Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...
FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The efficacy of the...
Patrizia Cavazzoni, MD, Named Director of the FDA’s Center for Drug Evaluation and Research
On April 12, Patrizia Cavazzoni, MD, was announced as the Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Janet Woodcock, MD, Acting Commissioner of the FDA, noted on Twitter: “Pleased to announce the permanent appointment of Patrizia ...
Tumor Mutational Burden as Predictor of Immune Response: Variance Between Female and Male Patients With Melanoma
Tumor mutational burden (TMB) was an accurate predictor of response to treatment with immune checkpoint inhibitors for female patients with melanoma, but not for male patients, according to results of a study presented by Sinha et al during the virtual American Association for Cancer Research...
FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer
On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor....
FDA Grants Regular Approval to Sacituzumab Govitecan-hziy for Pretreated Patients With Triple-Negative Breast Cancer
On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them...
FDA Approves New Dosing Regimen for Cetuximab in Colorectal Cancer, Head and Neck Cancer
On April 6, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux) of 500 mg/m2 as a 120-minute intravenous infusion every 2 weeks for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck. This...
Is Tumor Mutational Burden Alone Sufficient to Predict Response to Immunotherapy?
In a letter to the editor published in The New England Journal of Medicine, Benoit Rousseau, MD, and colleagues presented evidence that high tumor mutational burden (TMB) alone is not sufficient to predict improved outcomes with immune checkpoint inhibitor therapy in patients with solid tumors. As...
FDA Approves Isatuximab-irfc Combination for Relapsed or Refractory Multiple Myeloma
On March 31, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. IKEMA The efficacy...
FDA Approves New Indication for Daunorubicin/Cytarabine: Secondary AML in Pediatric Patients
On March 30, the U.S. Food and Drug Administration (FDA) approved a revised label for the combination of daunorubicin and cytarabine (Vyxeos) to include a new indication to treat newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (AML-MRC) in...
FDA Approves Idecabtagene Vicleucel for Heavily Pretreated Patients With Multiple Myeloma
On March 26, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 ...
Novel Therapies and New Indications for Use in the Treatment of Gastrointestinal Cancers
The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of novel drugs and new indications for treating patients with gastrointestinal malignancies. A summary of these approvals is provided herein. Nivolumab plus ipilimumab: On March 10, 2020, the FDA granted...
FDA Grants Two New Breakthrough Device Designations for Molecular Residual Disease Test
The U.S. Food and Drug Administration (FDA) granted two breakthrough device designations covering new intended uses of the Signatera molecular residual disease (MRD) test. These new designations will support the development of Signatera through phase III clinical trials as a companion diagnostic to ...
Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma
On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...
Development of Oral Taxane Tesetaxel to Be Discontinued
Following feedback from the U.S. Food and Drug Administration (FDA) in a pre–new drug application meeting, Odonate Therapeutics has concluded that the clinical data package for tesetaxel, an oral taxane tested in patients with metastatic breast cancer, is unlikely to support FDA approval....
FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma
On March 22, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the...
FDA Approves TheraSphere Y-90 Glass Microspheres for Unresectable Hepatocellular Carcinoma
Today, the U.S. Food and Drug Administration (FDA) approved TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma. The approval expands access to this therapy, which, to date, has been utilized under a humanitarian device exemption—an FDA...
FDA Pipeline: Priority Review for Kidney Cancer Treatment, Fast Track Designation for NSCLC Treatment
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to the HIF-2α inhibitor belzutifan for the treatment of patients with von Hippel-Lindau (VHL) disease–associated renal cell carcinoma. The agency also granted Fast Track designation to poziotinib for the treatment of...
High Tumor Mutational Burden Predicts Immunotherapy Response in Some—but Not All—Cancers
High tumor mutational burden (TMB) was useful for predicting clinical responses to immune checkpoint inhibitors only in a subset of cancer types, according to a study published by McGrail et al in Annals of Oncology. The findings suggest that TMB status may not be reliably used as a universal...
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved in the past 15 months alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and Drug ...
FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval
Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...
Increase in Breast Cancer Diagnoses After Pandemic-Related Screening Interruptions
More than a year into the COVID-19 pandemic, researchers are beginning to examine the effects of the virus in the larger health-care sphere. This week, we review a report on an observed increase in breast cancer diagnoses in Italy after pandemic-related screening interruptions. We also discuss two...
Repurposing Available Drugs for COVID-19: An Ongoing Initiative
As of this writing, no drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, although several have received emergency use authorization and many others are being used off-label during the pandemic. In addition to searching for novel therapies, David...
FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. TIVO-3 Efficacy was evaluated in TIVO-3 (ClinicalTrials.gov...
ASCO and Friends of Cancer Research Recommend Expanding Patient Access to Cancer Clinical Trials by Further Broadening Eligibility Criteria
ASCO and Friends of Cancer Research (Friends) jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients.1 The joint recommendations are detailed in a series of articles...
Kratom
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 Hou, PharmD, DipIOM, LAc, and Jyothirmai Gubili, MS, focus on...
Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma
On January 14, 2021, crizotinib was approved for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.1,2 The safety and efficacy of crizotinib have not been established in older...
Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations
On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...
Atezolizumab’s Indication in Previously Treated Metastatic Bladder Cancer Is Withdrawn
Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug...
FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. ZUMA-5 Approval in follicular lymphoma was based on a...
Recent Regulatory Decisions in Multiple Myeloma and Lung Cancer
This week, we’re discussing recent regulatory decisions, ranging from FDA approvals in multiple myeloma and non–small cell lung cancer to the withdrawal of a widely used drug’s indication for small cell lung cancer.
FDA Pipeline: Designations in Ovarian, Head/Neck, and Thyroid Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a novel immunotherapy for the treatment of ovarian cancer as well as Breakthrough Therapy designation to treatments for HRAS-mutant head and neck squamous cell carcinoma and previously treated thyroid cancer....
FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the...
Pembrolizumab's Indication in Small Cell Lung Cancer Is Withdrawn
On March 1, Merck announced the company is voluntarily withdrawing the U.S. indication for pembrolizumab (Keytruda) for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The ...
ASCO’s Road to Recovery Report Outlines Lessons Learned From the COVID-19 Pandemic to Improve Oncology Care
In 2020, ASCO established the Steering Group on Cancer Care Delivery and Research in a Post-Pandemic Environment to evaluate the changes made in oncology care delivery, clinical research, and regulatory oversight in response to the COVID-19 pandemic as well as to make recommendations on how to...
FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
On February 27, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older. The FDA...
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is...
EMPOWER-Lung 1: First-Line Cemiplimab-rwlc vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Sezer et al, the phase III EMPOWER-Lung 1 trial has shown improved overall and progression-free survival with cemiplimab-rwlc vs platinum doublet chemotherapy among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 50% of tumor cells...
New Report Reviews Methods for Reducing Waste, Improving Efficiency With Expensive Injectable Medications
Every year, significant amounts of drugs left over and unused from single-dose vials are discarded, but because of the way drugs are priced and paid for in the United States, the cost of the discarded amount cannot be recouped, according to a new congressionally mandated report from the National...
In Case You Missed It: Brief Highlights From ASH 2020
In case you missed these while attending the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, below is a sampler of highlights that were not included in our first round of meeting coverage. Many of these reports are on early-phase clinical trials of agents that may raise...
Novel Approaches in Chronic Lymphocytic Leukemia
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic approaches in chronic lymphocytic leukemia (CLL). For full...
B-Cell and T-Cell Non-Hodgkin Lymphomas
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on the assessment and treatment of patients with B-cell and T-cell non-Hodgkin...
How the COVID-19 Pandemic Can Help Improve Cancer Research
The ripple effects of the coronavirus pandemic have been felt in every area of health care. In our medical specialty, oncology, clinical trials of new treatments were upended by COVID-19. In the early months of the pandemic, widespread interruptions in trial enrollment prevented some patients...
Phase II CodeBreak 100 Validates Benefit of KRAS Inhibitor Sotorasib in Advanced Lung Cancer
The registrational phase II CodeBreak 100 trial has validated the power of KRAS inhibition with sotorasib (AMG 510) in advanced non–small cell lung cancer (NSCLC).1 In a follow-up to the groundbreaking findings of the phase I trial, the phase II cohort has now shown a durable response rate of...
FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression
On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved...
New Recommendations Aim to Eliminate Racial Disparities in Multiple Myeloma Therapies and Trials
Recommendations designed to address the underrepresentation of Black patients in clinical trials for multiple myeloma were recently released. Details about the initiative, published by Gormley et al in Blood Cancer Discovery, form a road map for designing multiple myeloma clinical trials to...
