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Showing 2001 - 2050FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
Potent Anti-HER2 Agents on the Horizon
THANKS TO the efficacy of five approved anti-HER2 agents, patients with HER2-positive breast cancer have overall survival numbers that are as good as, or better than, their HER2-negative counterparts. With the next generation of anti-HER2 therapies in clinical trials, these outcomes may become even ...
Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available
On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...
The Clinical Significance of Clinicaltrials.gov
“I think I found the trial that is going to save your life,” Stefanie Joho’s sister said after checking out the ClinicalTrials.gov website. “And sure enough, it did. That is not an exaggeration. That is exactly what happened,” Ms. Joho, a health advocate and consultant based in Philadelphia, told...
FDA Expands Nilotinib Indication to Pediatric Patients With CML
On March 22, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase. In the United ...
First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer
ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin,...
FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Previously Treated MSI-H or dMMR Metastatic Colorectal Cancer
On March 27, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults with microsatellite instability–high (MSI-H) or mismatch repair deficient...
FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL
The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...
FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
On March 26, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Breakthrough Therapy ...
FDA Updates Public Information About Known Risk of Lymphoma From Breast Implants
On March 21, the U.S. Food and Drug Administration (FDA) issued updated information about its understanding of breast implant–associated anaplastic large cell lymphoma (ALCL). The agency is providing an updated number of medical device reports (ie, adverse event reports) and medical...
FDA Expands Nilotinib Indication to Pediatric Patients With CML
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. In the United...
FDA Grants Priority Review to sNDA for Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
On March 19, a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of enzalutamide to include men with nonmetastatic...
FDA Expands Approval of Brentuximab Vedotin for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination With Chemotherapy
On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...
Why Right-to-Try Laws Are Dangerous
Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: [Editor’s Note: On May 30, 2018, the President signed into...
ASCO Names CAR T-Cell Immunotherapy Its Clinical Advance of the Year
This past January, ASCO published Clinical Cancer Advances 2018,1 its 13th annual report on the progress being made against cancer. The report names chimeric antigen receptor (CAR) T-cell immunotherapy as ASCO’s Advance of the Year. In 2017, the U.S. Food and Drug Administration (FDA) approved two ...
Cabozantinib Therapy Shows Activity in Differentiated Thyroid Cancer
Cabozantinib (Cometriq) has demonstrated significant activity in the first-line setting for radioiodine-refractory differentiated thyroid carcinoma, according to data from a single-site phase II trial presented at the 2018 Multidisciplinary Head and Neck Cancers Symposium.1 Treatment with...
FDA Grants Breakthrough Therapy Designation to Erdafitinib for the Treatment of Metastatic Urothelial Cancer
On March 15, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to erdafitinib for the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the United States. A Breakthrough Therapy ...
AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells
Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...
FDA Accepts Pembrolizumab sBLA for Treatment of Advanced Cervical Cancer
On March 13, Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental biologics license application (sBLA) and granted Priority Review for pembrolizumab (Keytruda), the company’s anti–programmed cell death protein 1 (PD-1) therapy. The application ...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer
On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. YS-ON-001 is a clinical-stage immuno-oncology biologic product with...
FDA Approves Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
On February 26, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. MONARCH 3 Approval...
Fast Food Nation and America’s Sick Diet
BOOKMARK Title: Fast Food Nation: The Dark Side of the All-American MealAuthor: Eric SchlosserOriginal Publisher: Houghton MifflinOriginal Publication Date: January 2001Price: $23.95, paperback, 288 pages The Centers for Disease Control and Prevention (CDC) estimates that about two-thirds of...
Cabozantinib in Advanced Renal Cell Carcinoma
ON DECEMBER 19, 2017, cabozantinib (Cabometyx) was granted regular approval for the treatment of advanced renal cell carcinoma.1,2 Cabozantinib was initially granted approval in 2016 for the treatment of patients with advanced renal cell carcinoma who had received prior antiangiogenic therapy. The...
Bosutinib in Newly Diagnosed Chronic-Phase Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 19, 2017, bosutinib (Bosulif) was granted...
Selected Abstracts From the San Antonio Breast Cancer Symposium
EACH YEAR, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer...
Lutetium Lu-177 Dotatate in Gastroenteropancreatic Neuroendocrine Tumors
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...
Apalutamide, Enzalutamide Improve Metastasis-Free Survival in Nonmetastatic Castrate-Resistant Prostate Cancer
IN TWO SEPARATE TRIALS presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial,1,2...
FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications
On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...
FDA Authorizes Direct-to-Consumer Test That Reports Three Mutations in the BRCA1/BRCA2 Breast Cancer Genes
Today, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in...
Multitargeted Tyrosine Kinase Inhibitor Shows Activity in Small Cell Carcinoma of the Ovary
An multitargeted tyrosine kinase inhibitor used to treat leukemia has shown promise against a rare and aggressive type of ovarian cancer—small cell carcinoma of the ovary hypercalcemic type (SCCOHT)—that strikes young women and girls, according to a study led by the Translational...
ASCO, NCCN Provide Guidance on Understanding and Managing Immunotherapy Side Effects
Immunotherapy with immune checkpoint inhibitors is the first of a new generation of immunotherapy treatments, revolutionizing treatment for many different types of cancer. By unleashing the body’s immune system to attack cancer, these treatments can send even the most hard-to-treat cancers into...
Alex Huang, MD, PhD, Receives $450,000 From Pediatric Cancer Research Foundation
Cancer researcher Alex Huang MD, PhD, has received a $450,000 Basic Science grant from the Pediatric Cancer Research Foundation to study targeted approaches for effectively eliminating metastatic osteosarcoma. Dr. Huang is Professor of Pediatrics at Case Western Reserve University School of...
Why Right-to-Try Laws Are Dangerous
Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: On May 30, 2018, the President signed into law the Trickett...
FDA Grants Fast Track Designation to Pamrevlumab in Locally Advanced Unresectable Pancreatic Cancer
On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical...
GC4419 Receives FDA Breakthrough Therapy Designation for the Reduction of Severe Oral Mucositis
On February 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419, a highly selective and potent small molecule dismutase mimetic, for the reduction of the duration, incidence, and severity of severe oral mucositis induced by radiation therapy with...
FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia
On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
FDA Approves Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
On February 26, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced...
FDA Grants Orphan Drug Designation to YS-ON-001 for the Treatment of Pancreatic Cancer
On February 26, Yisheng Biopharma Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer. YS-ON-001 is a clinical-stage immuno-oncology biologic product...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
FDA Approves Abiraterone Acetate Plus Prednisone for High‑Risk Metastatic Castration-Sensitive Prostate Cancer
ON FEBRUARY 7, 2018, the U.S. Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer. The FDA initially approved abiraterone acetate with prednisone in 2011 for patients with...
Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients With Advanced NSCLC
On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent, or metastatic non–small cell lung cancer (NSCLC) whose disease progressed after treatment with a...
FDA’s Oncologic Drugs Advisory Committee to Review Potential New Use of Blinatumomab
On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...
FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression
On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...
Clinical Hold on BPX-501 Trials in the United States Announced
On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed on a clinical hold ...
ASCO and NCCN Provide Guidelines for Managing Immunotherapy Side Effects
Immunotherapy with immune checkpoint inhibitors is the first of a new generation of immunotherapy treatments, revolutionizing treatment for many different types of cancer. By unleashing the body's immune system to attack cancer, these treatments can send even the most hard-to-treat cancers into...
FDA Approves Apalutamide for Nonmetastatic, Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) today approved apalutamide (Erleada) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for nonmetastatic,...
FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC
On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018. Lorlatinib is an investigational, anaplastic lymphoma...
FDA Grants Premarket Approval to New HPV Assay
On February 14, Becton, Dickinson and Company (BD) announced it had received premarket approval from the U.S. Food and Drug Administration (FDA) for the BD Onclarity human papillomavirus (HPV) assay. The test detects 14 types of high-risk HPV from specimens collected for cervical cancer screening...
2018 GU CANCERS SYMPOSIUM: Combination Therapy Shows Antitumor Activity in Advanced Renal Cell Carcinoma
Combining the antiangiogenic agent axitinib (Inlyta) with the immunotherapy pembrolizumab (Keytruda) was found to have promising antitumor activity and no unexpected side effects in an early-phase clinical trial in patients with advanced kidney cancer who had not been previously treated. The full...
