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Showing 3501 - 3550AACR 2015: Pembrolizumab Safe, With Signs of Clinical Benefit, for Patients With Malignant Pleural Mesothelioma
Pembrolizumab (Keytruda) was safe, tolerable, and yielded robust antitumor responses in patients with malignant pleural mesothelioma, according to data from the phase Ib KEYNOTE-028 clinical trial presented at the AACR Annual Meeting 2015, held April 18 to 22 in Philadelphia (Abstract CT103)....
Study Finds Oncology Drug Pricing Models ‘Not Rational’
A statistical analysis of 51 oncology drugs approved by the U.S. Food and Drug Administration (FDA) between January 1, 2009, and December 31, 2013, has found that cancer drug prices are rising faster than the prices in other sectors of health care and that the high cost of the drugs is not...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with...
Addition of Bevacizumab to Chemotherapy Extends Survival in Women With Platinum-Sensitive Recurrent Ovarian Cancer
In a phase III study of women with ovarian cancer, researchers found that the addition of bevacizumab (Avastin) to standard chemotherapy extended median overall survival by 5 months compared to standard chemotherapy alone. The bevacizumab combination was also associated with a significant...
FDA Grants Priority Review to Carfilzomib Supplemental New Drug Application for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted Amgen’s supplemental New Drug Application (sNDA) for carfilzomib (Kyprolis) injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the...
Annual ASCO Report Shows Widespread Disturbance in Oncology Practice, Amid Growing Patient Demand and Administrative Burden
The U.S. cancer care system faces tremendous turbulence while dealing with growing numbers of cancer patients and survivors, mounting pressures to control rising health-care costs, and widespread oncology practice transformation, reports a new study by the American Society of Clinical Oncology...
FDA Approves Dinutuximab Combination for Pediatric Patients With High-Risk Neuroblastoma
The U.S. Food and Drug Administration has approved dinutuximab (Unituxin) as part of first-line therapy for pediatric patients with high-risk neuroblastoma. Dinutuximab, a chimeric monoclonal antibody that binds to the surface of neuroblastoma cells, is being approved for use as part of a...
Neoadjuvant Chemotherapy for Breast Cancer Increases Chances of Lumpectomy, Decreases Chances of Mastectomy
Patients with larger malignant tumors of the breast who undergo chemotherapy before a breast cancer operation are more likely to undergo a lumpectomy than a mastectomy, according to a study published by Killelea et al in the Journal of the American College of Surgeons. Study investigators from...
FDA Approves First Biosimilar Product Filgrastim‑Sndz
The U.S. Food and Drug Administration (FDA) today approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
Study Finds Websites That Market Personalized Cancer Care Services Overemphasize Benefits
A recent analysis of 55 Internet websites marketing a broad range of tests and services that promise the ability to personalize cancer treatment has found that the websites often overemphasize their purported benefits and downplay their limitations. In addition, the study results show that the...
FDA Approves Nivolumab to Treat Metastatic Squamous Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the PD-1 inhibitor nivolumab (Opdivo) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that binds ...
Early Study Shows Cabazitaxel May Be More Effective Than Docetaxel in Some Patients With Advanced Prostate Cancer
In a new study reported by de Leeuw et al in Clinical Cancer Research, researchers found that the novel taxane cabazitaxel (Jevtana) has properties that could make it more effective than docetaxel in some patients with advanced prostate cancer. This hypothesis is currently being tested in a phase...
Human Reovirus Formulation Receives FDA Orphan Drug Designation for Fallopian Tube Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of fallopian tube cancer. The designation was granted on the basis of the company's December 2014 application for ...
FDA Grants Breakthrough Therapy Designation to EBV-Targeted T Cells for Treatment of EBV-Associated Lymphoproliferative Disease
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Memorial Sloan Kettering Cancer Center and Atara Biotherapeutics’ optioned cytotoxic T lymphocytes activated against Epstein-Barr virus (EBV-CTL) in the treatment of patients with rituximab...
FDA Approves Panobinostat Combination for the Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) today approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma. Panobinostat is the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma. It is...
FDA Analysis Explores Relationship Between Response Rate and Survival at Trial and Patient Levels in Advanced NSCLC Studies
In a U.S. Food and Drug Administration (FDA) analysis of randomized trials in advanced non–small cell lung cancer (NSCLC) reported in the Journal of Clinical Oncology, Blumenthal et al found a strong correlation between response rate and progression-free survival at the trial level and a...
FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
Early Study Suggests Olaparib May Be Effective in Ovarian Cancers Expressing High Levels of POLQ
Last December, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in the treatment of advanced ovarian cancer in women with BRCA1 or BRCA2 gene mutations. Now, a laboratory study by Ceccaldi et al has found that the drug may also be effective in breast and ovarian tumors that...
FDA Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The U.S. Food and Drug Administration (FDA) today granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...
FDA Grants Orphan Drug Designation to Human Reovirus Formulation for the Treatment of Ovarian Cancer
Oncolytics Biotech, Inc, a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its proprietary formulation of the human reovirus...
Widespread Use of Docetaxel Preceded Phase III Evidence of Usefulness in Patients With Metastatic Prostate Cancer
Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than standard-of-care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and...
Study Shows Immunosuppressives, Chemotherapy May Reactivate Hepatitis B
Individuals previously infected with the hepatitis B virus (HBV) that receive chemotherapy or immunosuppressive treatment may be at risk of reactivating the virus, according to a report published by Di Bisceglie et al in Hepatology. Reactivation of HBV can be fatal, and researchers suggest routine...
FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer
The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy. ...
FDA Grants Priority Review for Trabectedin for the Treatment of Patients With Advanced Soft-Tissue Sarcoma
Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have...
FDA 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...
