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Showing 1951 - 2000FDA Grants Orphan Drug Designation to BN-Brachyury for the Treatment of Chordoma
On May 2, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the cancer vaccine BN-Brachyury for the treatment of chordoma. Chordoma is a rare type of cancer that develops along the spine, with presentation occurring at one of three main sites: sacrum, mobile spine, or...
FDA Accepts sBLA, Grants Priority Review for Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy in Metastatic Nonsquamous NSCLC
On April 30, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) based on results of the phase III KEYNOTE-189 trial. The application seeks approval for pembrolizumab in combination with pemetrexed (Alimta) ...
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and...
Characteristics of FDA-Designated Breakthrough and Nonbreakthrough Cancer Drugs
In a study reported in the Journal of Clinical Oncology, Hwang et al found little difference in the efficacy and safety of U.S. Food and Drug Administration (FDA)-designated breakthrough vs nonbreakthrough cancer drugs and found that breakthrough drugs were not more likely to represent a novel...
FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations
On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...
Update Regarding Tazemetostat Clinical Program
On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...
FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC
On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. ...
CB-839 in Combination With Cabozantinib for Advanced RCC Granted FDA Fast Track Designation
On April 18, Calithera Biosciences, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-839 in combination with cabozantinib (Cabometyx) for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines ...
FDA Grants Fast Track Designation for Balixafortide in Combination With Eribulin as Third-Line Therapy for Metastatic Breast Cancer
On April 19, Polyphor announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326) in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who...
Postmarketing Label Modifications for Cancer Drugs Approved Without Supporting Randomized Controlled Trials
In a study reported in the Journal of Clinical Oncology, Shepshelovich et al found that cancer drugs approved by the U.S. Food and Drug Administration (FDA) for treatment of solid tumors without supporting randomized controlled trials were more likely to have postapproval safety-associated label...
FDA Unveils Streamlined Path for Authorizing Tumor-Profiling Tests Alongside Its Latest Product Action
The U.S. Food and Drug Administration (FDA) recently finalized two guidances to drive the efficient development of next-generation sequencing, which scans a person’s DNA to diagnose genetic diseases, and guide medical treatments. The guidances provide recommendations for designing,...
FDA Approves Osimertinib for First-Line Treatment of Metastatic NSCLC With Most Common EGFR Mutations
On April 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as...
FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients
On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...
ASCO Honors Leaders in Cancer Care With 2018 Special Awards
ASCO and ASCO’s Conquer Cancer Foundation are proud to recognize the winners of ASCO’s Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards. The recipients of these awards include researchers, patient advocates, and global oncology leaders who have worked to transform...
Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined...
Enormous Cost of Failure to Screen Heavy Smokers for Lung Nodules
In 2011 the American College of Radiology Imaging Network (ACRIN) group published its publicly funded study of three annual screening chest computed tomography (CT) scans among heavy smokers aged 55 to 74.1 The results remain the first and only screening study for any cancer demonstrating a...
FDA Approves Nivolumab/Ipilimumab Combination in Intermediate- or Poor-Risk Advanced RCC
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC). CheckMate 214 The approvals were based on...
FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
Clinical Hold Lifted on U.S. Studies of BPX-501
On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...
Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma
On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The FDA’s...
FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations
On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...
FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer
Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...
FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer
On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....
Is CAR T-Cell Therapy Setting a New Standard of Care in Lymphoma?
Data presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition on the longer-term follow-up analysis of results from the ZUMA-1 trial investigating the effectiveness of axicabtagene ciloleucel (Yescarta) in patients with refractory non-Hodgkin lymphoma (NHL) showed...
FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma
ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and...
FDA 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...
