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Showing 1851 - 1900Real-World Evidence Gaining Credibility and Practicality in Treatment Evaluation
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends...
Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings in ...
FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...
FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. L-PLUS 1 and L-PLUS 2 Approval was based on two randomized, double-blind, placebo-controlled...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types....
FDA Approves Magnetic Device System for Guiding Sentinel Lymph Node Biopsies in Patients With Breast Cancer
The U.S. Food and Drug Administration (FDA) recently approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to ...
Pseudosophisticated Language and Needless Confusion?
I’ve been a loyal ASCO member since the early 1970s (aka “back in the day”) and wanted to share a growing pet peeve. I thought of attacking an individual author, but my sense tells me the source of my annoyance is really now a cultural problem and one that can only be fixed at the editor level....
Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer
ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The...
Pegfilgrastim-jmdb as Biosimilar to Pegfilgrastim to Decrease Risk of Infection During Cancer Treatment
On June 4, 2018, pegfilgrastim-jmdb (Fulphila) was approved as a biosimilar to pegfilgrastim (Neulasta) to decrease infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia.1,2 Approval Basis Approval...
Opportunities, Issues, and Challenges for Biosimilars in Oncology
In an article published recently in TheNew England Journal of Medicine, Gary H. Lyman, MD, MPH, FACP, FRCP (Edin), FASCO, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues reviewed opportunities, issues, and challenges posed by the advent of biosimilar medications, focusing on...
FDA Grants Breakthrough Therapy Designation for Atezolizumab/Bevacizumab Combination as First-Line Treatment for Advanced or Metastatic HCC
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver...
Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
EARLY IN 2018, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.1,2...
Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
FDA Approves Enzalutamide for Castration-Resistant Prostate Cancer
ON JULY 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with either nonmetastatic CRPC or metastatic CRPC. Enzalutamide was ...
FDA Accepts BLA, Grants Priority Review for Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a biologics license application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for...
FDA Approves Filgrastim Biosimilar Filgrastim-aafi
On July 20, the U.S. Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym), a biosimilar to filgrastim (Neupogen), for all eligible indications of the reference product. “The FDA approval of filgrastim-aafi marks an important step in helping expand access to critical...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
In Case You Missed It: Short Takes on Current Cancer Research
It would be impossible to cover all of the important presentations from the 5,000-plus abstracts accepted for the 2018 ASCO Annual Meeting. In addition to our regular meeting coverage of the top news stories, the following highlights focus on novel investigational approaches to therapy for various...
Nivolumab Plus Low-Dose Ipilimumab Approved for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
On July 11, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial...
FDA Grants Priority Review to sBLA for Pembrolizumab in Advanced Hepatocellular Carcinoma
The U.S. Food and Drug Administration (FDA) recently accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as a second-line treatment for patients with advanced hepatocellular carcinoma. This sBLA, which is...
FDA Approves Enzalutamide for Castration-Resistant Prostate Cancer
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with either nonmetastatic CRPC or metastatic CRPC. Enzalutamide was ...
Statement by FDA Commissioner on Opioid Access for Patients With Chronic and End-of-Life Pain
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement. The opioid epidemic continues to take an emotional, physical, and financial toll on Americans. The FDA is committed to taking every possible step to address the many facets of this...
FDA Approves Nivolumab Plus Low-Dose Ipilimumab for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR)...
FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung...
FDA Grants Orphan Drug Designation to CPI-613 for Treatment of Burkitt Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of Burkitt lymphoma. Burkitt lymphoma is a highly aggressive hematologic B-cell malignancy classically characterized by the overexpression of c-Myc. Due to the rapid proliferation rate of...
Excerpt From the 2018 ASCO Presidential Address: ‘Delivering Discoveries: Expanding the Reach of Precision Medicine’
In my area of research, lung cancer, precision medicine is indeed transforming the treatment of this disease and has important implications for other cancers and for the future of our patients with cancer. Today’s achievement of being able to systematically identify genomic changes that can be...
Outcomes in Patients With Melanoma Treated With Anti–PD-1 Antibody Beyond Disease Progression
A POOLED analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond disease progression on Response Evaluation Criteria in Solid Tumors (RECIST) in some patients receiving anti–programmed cell death protein 1 (anti–PD-1) antibodies for unresectable or...
Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
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. Earlier this year, apalutamide (Erleada) was approved for ...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK...
FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...
IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
FDA Takes Steps to Foster Greater Efficiency in Biosimilar Development by Reconsidering Draft Guidance on Evaluating Analytical Studies
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the US Food and Drug Administration (FDA) can do more to support the development of biosimilars, as well as...
FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...
FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...
FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer
ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...
Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer
THE U.S. FOOD and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...
I’m Proud to Have Contributed to the FDA Approval of CAR T-Cell Therapy
When I was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2013, I used to joke that if I had to get cancer, this wasn’t a bad one to have. At just 32, I was otherwise healthy, and my prognosis for a cure was good, according to my oncologist. So I felt confident that once I underwent...
FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9). The application is seeking approval for an expanded age...
Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for ...
EHA 2018: Tisagenlecleucel Demonstrates More Than 1-Year Durability of Response in Adults With Relapsed or Refractory DLBCL
Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...
FDA Clears Expanded Indication of Scalp-Cooling System
Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as...
FDA and EMA Accept Regulatory Submissions for Review of Talazoparib for Patients With Germline BRCA-Mutated Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted Priority Review designation a new drug application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib vs chemotherapy in patients with germline BRCA-mutated,...
