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Showing 901 - 950Douglas R. Lowy, MD, FAACR, Honored With 2021 AACR–Margaret Foti Award
The American Association for Cancer Research (AACR) presented Douglas R. Lowy, MD, FAACR, with the 2021 AACR–Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research during the virtual AACR Annual Meeting 2021. Dr. Lowy is Chief of the Laboratory of Cellular Oncology,...
FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic EGFR Exon 20 Insertion–Mutated NSCLC
On May 21, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant), a bispecific antibody directed against epidermal growth factor and MET receptors, for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and...
FDA Pipeline: Applications Accepted for Marginal Zone Lymphoma and Lung Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to zanubrutinib in pretreated patients with marginal zone lymphoma, and accepted a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line...
FDA Approves Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer
On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMate ...
FDA Pipeline: Priority Reviews in Kidney and Endometrial Cancers, Cholangiocarcinoma
Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents
On May 10, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents aged 12 through 15. The FDA...
Margetuximab-cmkb: A Novel Agent Overshadowed by an Abundance of Options in HER2-Positive Breast Cancer
It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...
Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...
FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma
On April 16, 2021, 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...
Cannabis
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 article, Nirupa Raghunathan, MD, and Jyothirmai Gubili, MS, focus on the increasing use...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at PER’s Miami Breast Cancer Conference, held virtually this year, by Adam M....
FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer
On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
Expanding Role of Liquid Biopsies in Cancer Detection and Therapeutics: Now and in the Near Future
“It is possible that within the next several years, perhaps 75% of cancers can be detected by screening,” Bert Vogelstein, MD, PhD, projected at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 “I anticipate that perhaps 50% of cancers can be detected...
FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer
More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...
FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
Updated Information on Sotorasib Dose-Comparison Study
Amgen has announced that it agreed with the U.S. Food and Drug Administration's proposed postmarketing requirement to conduct, as part of the ongoing development program, a multicenter randomized clinical trial to compare the safety and efficacy of sotorasib at 960 mg once daily vs a lower daily...
New Research Finds Few Young Adult Men Have Received the HPV Vaccine
Using data from the 2010–2018 National Health Interview Surveys, Chen et al found that just 16% of men who were 18 to 21 years old had received at least one dose of the human papillomavirus (HPV) vaccine at any age. In comparison, 42% of women in the same age bracket had gotten at least one shot of ...
FDA ODAC Votes in Favor of Maintaining Accelerated Approval of Atezolizumab/Nab-paclitaxel for PD-L1–Positive, Metastatic Triple-Negative Breast Cancer
Roche announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, or nab-paclitaxel) for the treatment of ...
FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma
On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, ...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have...
Ethical Considerations Before Launching a Clinical Cancer Trial
Randomized clinical trials are highly regulated initiatives that must comply with multiple requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions surrounding immunotherapy and targeted agents become more complex. To shed...
A Physician-Scientist’s Mother, Who Nursed Those With Chronic Diseases, Fueled His Passion for Biomedical Research
For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, spoke with Griffin P. Rodgers, MD, MACP, Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Dr. Rodgers, a physician-scientist,...
Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...
‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting
In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...
FDA 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...
