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Showing 1801 - 1850AACR Releases Annual Cancer Progress Report
The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer. Key advances outlined...
Recent Drug Approvals and Revisions in Prescribing Information
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable...
FDA Approves First Nonchemotherapy Combination Regimen for Patients With Waldenström’s Macroglobulinemia
ON AUGUST 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) for patients with Waldenström’s macroglobulinemia. The recent approval expands the label for ibrutinib in Waldenström’s macroglobulinemia beyond its current...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for Treatment of Lung and Thyroid Cancers
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) who require systemic therapy and have had...
Treating Nonmetastatic Castration-Resistant Prostate Cancer: Implications of the PROSPER Trial
A MAN in his early 70s sits in our office. His general health is good, and he is feeling well. Yet he is deeply worried. Four years ago, when his prostate-specific antigen (PSA) level rapidly increased after radical prostatectomy and subsequent radiation therapy, he was started on...
FDA Grants Priority Review to sBLA for Pembrolizumab in Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking accelerated approval for pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast 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. On July 18, 2018, the indication for ribociclib (Kisqali) ...
Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer
On July 10, 2018, ipilimumab (Yervoy) was granted accelerated approval for use in combination with nivolumab (Opdivo) for the treatment of patients at least 12 years of age with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer progressing...
Improving the Lives of Patients With Cancer Is Richard L. Schilsky’s Lifelong Mission
In 2009, as Richard L. Schilsky, MD, FACP, FSCT, FASCO, was preparing his Presidential Address for that year’s ASCO Annual Meeting, he came across his 6th grade essay titled “My Ambition,” which foretold with eerie specificity the career path he would follow over the next 6 decades. In the paper,...
FDA Accepts sBLA for Dasatinib in Pediatric Patients With Newly Diagnosed Ph-Positive ALL
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia...
Statement From FDA Commissioner on Support for Exempting Coffee From California’s Cancer Warning Law
Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, recently issued the following statement: “Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the FDA. Consumers deserve accurate information about the food they eat and how ...
FDA Approves cobas EGFR Mutation Test v2 as Companion Diagnostic With Gefitinib in First-Line Treatment of NSCLC
The U.S. Food and Drug Administration (FDA) recently approved the cobas EGFR Mutation Test v2 as a companion diagnostic test with gefitinib (Iressa) for the first-line treatment of patients with non–small cell lung cancer (NSCLC). A companion diagnostic test provides information that is...
FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...
CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents
The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...
FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab,...
FDA Grants Fast Track Designation to AVB-S6-500 for Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. About AVB-S6-500 AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL...
Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...
Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA...
FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...
FDA Grants Orphan Drug Designation to CPI-613 for the Treatment of Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle. This drug is...
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Pembrolizumab...
FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma
On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...
FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer
Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...
FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy
The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...
Enzalutamide 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. On July 13, 2018, enzalutamide (Xtandi) was approved for...
FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma
Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...
Navigating the ‘New Normal’: NCCN Summit Examines Access to High-Quality Cancer Care
It’s not just the leaps in development of precision medicines, the soaring costs, the new payment models, clinical trial designs, sources of data, and federal policies. It’s all of them plus the rapidity with which change is happening that makes this era of oncology exceptional. “I would say...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Medical Marijuana: Research Not Anecdotes
For patients with cancer, marijuana may be valuable in controlling pain and chemotherapy-induced nausea and vomiting. Furthermore, it may have efficacy as an appetite stimulant. No randomized clinical trial has investigated the utility of whole-plant medical marijuana to alleviate these symptoms in ...
VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...
Drug Combination Design for Multiple Myeloma Using an AI Platform
A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...
FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis
iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast...
FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy
PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...
FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...
FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids
Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...
FDA Approves HPV Test for First-Line Cervical Cancer Screening
ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test...
Meeting the Challenges of Immunotherapy-Related Toxicities
In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
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. This past June, encorafenib (Braftovi) and binimetinib...
FDA Approves First Treatment for Rare Adrenal Tumors
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection (Azedra) for intravenous use in the treatment of adults and adolescents aged 12 and older with unresectable pheochromocytoma or paraganglioma that have spread beyond the original tumor site and require ...
ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation
ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...
Guidelines for Pediatric CAR T-Cell Therapy Developed
Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On July 18, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali), in combination with an aromatase inhibitor for pre/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based...
Durvalumab After Chemoradiation in Unresectable Stage III NSCLC
Early in 2018, durvalumab (Imfinzi) was approved for the treatment of unresectable stage III non–small cell lung cancer (NSCLC) that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.1,2 Supporting Efficacy Data Approval was based on a planned interim...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
Expert Point of View: Rajesh Lalla, DDS, PhD
COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, “This study demonstrated this agent’s strong potential for the management of oral mucositis in patients receiving head and neck radiation...
Why Oncologists Should Decline to Participate in the Right to Try Act
ON MAY 30, 2018, President Donald J. Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.1 This law creates an additional and alternative pathway for patients with a “life-threatening disease or condition” to access...
FDA Grants Breakthrough Therapy Designation to Quizartinib for Relapsed/Refractory FLT3-ITD AML
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...
FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
