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Showing 3551 - 3600FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Genentech’s investigational cancer immunotherapy MPDL3280A for the treatment of PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based...
FDA Approves New Indication for Ibrutinib in Waldenström's Macroglobulinemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s...
Supplemental New Drug Application Submitted for Carfilzomib for Relapsed Multiple Myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at...
CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine-daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia. The FDA established the...
Expanded Analyses of Phase III MM-398 NAPOLI-1 Study Substantiate Positive Results of MM-398 Combined With Fluorouracil/Leucovorin
Additional analyses from the global phase III NAPOLI-1 study of MM-398 (aka PEP02), a nanoliposomal encapsulation of irinotecan, in metastatic pancreatic cancer were presented by Chen et al in an oral session at the 2015 Gastrointestinal Cancers Symposium (Abstract 234). The primary analysis ...
Almost Half of Women Taking Tamoxifen for Primary Prevention of Breast Cancer Discontinue Use Before 5 Years
After 4.5 years of taking tamoxifen for primary prevention of breast cancer, 46% of women discontinued use, according to research conducted within the Sister Study, a prospective cohort of women who had a sister who had been diagnosed with breast cancer but did not have breast cancer themselves....
Second-Line Ramucirumab Added to Standard Chemotherapy Improves Survival in Patients With Advanced Colorectal Cancer
New findings from an international phase III study of 1,072 patients with advanced colorectal cancer whose disease progressed on or after initial therapy indicate that a combination of the targeted drug ramucirumab (Cyramza) and FOLFIRI (irinotecan, fluorouracil, leucovorin) chemotherapy provides a ...
FDA Grants Fast Track Designation to SGX301 for First-Line Treatment of Cutaneous T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Soligenix’s synthetic hypericin (SGX301) development program for the first-line treatment of cutaneous T-cell lymphoma. Fast Track designation is reserved for drugs that demonstrate the potential to address an...
Bispecific CD19-Directed CD3 T-Cell Engager Blinatumomab Active in Adults With Relapsed/Refractory B-Cell Precursor ALL
In a phase II study reported in The Lancet Oncology, Topp et al found that the bispecific CD19-directed CD3 T-cell engager (BiTE) blinatumomab (Blincyto) was highly active in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab binds to CD19 expressed ...
FDA Approves Nivolumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is intended for patients who have been previously treated with ipilimumab...
FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer
Today’s approval by the U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian...
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three ...
FDA Approves Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) today approved lanreotide (Somatuline Depot Injection) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. Lanreotide was previously approved for...
FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK...
FDA Approves Nine-Valent HPV Vaccine for Prevention of Certain Cancers Caused by Five Additional Types of HPV
The U.S. Food and Drug Administration (FDA) today approved recombinant nine-valent human papillomavirus vaccine (Gardasil 9) for the prevention of certain diseases caused by nine types of HPV. The nine-valent vaccine covers five more HPV types than the previously approved quadrivalent vaccine...
FDA Approves Denosumab for the Treatment of Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
The U.S. Food and Drug Administration has approved a new indication for denosumab (Xgeva) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Denosumab was approved and granted Orphan Drug designation by the FDA, which is reserved for drugs that are intended for...
ASH 2014: Post-Transplant Brentuximab Vedotin Improves Progression-Free Survival in Hodgkin Lymphoma Patients
In Hodgkin lymphoma patients at risk for disease progression following autologous stem cell transplant, early consolidation post-transplant with brentuximab vedotin (Adcetris) significantly improved progression-free survival compared with placebo in the phase III AETHERA trial. The findings were...
FDA Approves Ruxolitinib to Treat Patients With Polycythemia Vera
The U.S. Food and Drug Administration (FDA) today approved a new use for ruxolitinib (Jakafi) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Ruxolitinib, a JAK inhibitor, is the first drug approved by the FDA for this condition. Polycythemia vera occurs when too...
Ixazomib Receives Breakthrough Therapy Designation for Relapsed or Refractory Systemic Light-Chain Amyloidosis
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy status to Takeda Pharmaceuticals’ investigational, oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain amyloidosis. This is the first proteasome inhibitor...
FDA Approves Blinatumomab to Treat Rare Form of Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to blinatumomab (Blincyto) for the treatment of patients with Philadelphia chromosome–negative, relapsed or refractory precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blinatumomab is a bispecific...
Bisphosphonates May Block the Development of HER-Driven Tumors, Preventing Breast, Lung, and Colon Cancers
Two studies have found that bisphosphonates may be effective in preventing certain cancers—including lung, breast, and colon—by blocking abnormal growth signals passed through HER family receptors. The studies suggest that bisphosphonates, the most commonly prescribed medications for...
Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib as a first-line treatment in combination with paclitaxel and gemcitabine in patients with metastatic pancreatic cancer. Necuparanib is a novel oncology drug candidate engineered from...
FDA Grants Breakthrough Therapy Designation to Investigational CAR T-Cell Therapy
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was filed...
FDA Warns Against Using Laparoscopic Power Morcellators to Treat Uterine Fibroids
The U.S. Food and Drug Administration (FDA) today announced that it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warned against using...
FDA Approves Extended-Release, Single-Entity Hydrocodone Product With Abuse-Deterrent Properties
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate (Hysingla ER), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product...
FDA Grants Orphan Drug Designation to BGB324 for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BGB324 for the treatment of acute myeloid leukemia (AML). BGB324 is a first-in-class, highly selective small-molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition...
FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer
The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. AURELIA Trial ...
FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The U.S. Food and Drug Administration (FDA) today approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of...
Oncology Advances Included in Cleveland Clinic's Top 10 Medical Innovations List for 2015
Antibody-drug conjugates, checkpoint inhibitors, and single-dose intraoperative radiation therapy for breast cancer were included in the Cleveland Clinic's Ninth Annual Top 10 Medical Innovations List released earlier today. The list identifies those advances likely to have a major impact on...
FDA Grants Breakthrough Therapy Designation Pembrolizumab in Advanced Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the anti–PD-1 therapy pembrolizumab (Keytruda) for the treatment of patients with epidermal growth factor receptor (EGFR) mutation–negative, and anaplastic lymphoma kinase (ALK)...
TAS-102 Receives FDA Fast Track Designation for Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Taiho Oncology’s TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer. TAS-102 is an oral combination investigational anticancer drug consisting of...
FDA Grants Lenvatinib Priority Review Designation for Advanced Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer and granted the application Priority Review status. Lenvatinib is an oral multiple...
FDA Approves Expanded Use of Tilmanocept for Lymphatic Mapping in Solid Tumors
The U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application for the expanded use of technetium 99m tilmanocept (Lymphoseek Injection) for lymphatic mapping in solid tumors and for adding sentinel lymph node detection for breast cancer and melanoma to the approved...
FDA Grants Priority Review to Palbociclib as First-Line Therapy in Combination With Letrozole in Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Pfizer’s New Drug Application for palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor–positive, HER2-negative advanced breast cancer...
Blinatumomab Receives FDA Priority Review Designation in Acute Lymphoblastic Leukemia
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the ...
FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was...
FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting
The U.S. Food and Drug Administration (FDA) today approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron,...
FDA Grants Orphan Drug Designation to DNX-2401 for Malignant Glioma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to DNAtrix’s DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Glioma is the most common form of primary brain cancer, the treatment of which remains a significant unmet medical...
FDA Grants Orphan Drug Designation to Investigational Agent for Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to pegylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. Halozyme Therapeutics is currently investigating PEGPH20 in a phase II study in combination with gemcitabine and...
FDA Grants Breakthrough Therapy Designation to AP26113 for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Ariad Pharmaceutical’s investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who are resistant to crizotinib...
Next-Generation HPV Vaccine May Prevent 90% of Cervical Cancer Cases Worldwide
A study of a nine-valent human papillomavirus (HPV) vaccine that provides protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, has found it to be highly safe and efficacious. If vaccination programs with this new-generation vaccine are effectively implemented, approximately 90% of...
ESMO 2014: Adding Cediranib to Chemotherapy Improves Progression-Free Survival in Metastatic or Recurrent Cervical Cancer
For patients with recurrent or metastatic cervical cancer, adding the experimental drug cediranib to standard chemotherapy improved tumor shrinkage and resulted in a modest improvement in progression-free survival, researchers reported at the ESMO 2014 Congress in Madrid (Abstract LBA25_PR). In...
Aldoxorubicin Receives FDA Orphan Drug Designations for Glioblastoma, Small Cell Lung Cancer, and Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and...
FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to...
Tyrosine Kinase Inhibitors May Improve Treatment Outcomes in Children With Philadelphia Chromosome–Like ALL
Using genomic profiling and next-generation sequencing of patients with BCR-ABL1-like B-progenitor acute lymphoblastic leukemia (B-cell ALL) and Philadelphia chromosome–like ALL, researchers recently identified alterations targeting 18 kinase or cytokine receptor genes. They then determined...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation...
Study Identifies Two Novel ALK Mutations Causing Lung Cancer Resistance to ALK Inhibitors
In a recent study investigating alectinib resistance in ALK-positive lung cancers, researchers identified two novel ALK mutations that are sensitive to ceritinib (Zykadia), a next-generation ALK tyrosine kinase inhibitor approved by the FDA earlier this year for advanced non–small cell lung...
AACR’s 2014 Cancer Progress Report Stresses Research Advances and More Federal Funding
The American Association for Cancer Research (AACR) released its 2014 Cancer Progress Report today, which highlights the quickening pace of drug development and approval, especially in molecularly targeted agents that are leading to increased numbers of cancer survivors. However, the report also...
FDA Approves New Indication for Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved a new indication for the use of enzalutamide (Xtandi) capsules to treat patients with metastatic castration-resistant prostate cancer. The new indication is for men with metastatic castration-resistant prostate cancer who have not received...
FDA Approves Pembrolizumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following...
