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Showing 1951 - 2000Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma
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 May 1, 2018, tisagenlecleucel (Kymriah), a...
Weighing the Cost and Value of CAR T-Cell Therapy
This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, 2018, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/-Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar is...
FDA Approves Daratumumab/VMP Combination for Newly Diagnosed Multiple Myeloma
On May 7, the U.S. Food and Drug Administration(FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for...
Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events
The publication of ASCO’s toxicity management guidelines for immune checkpoint antibodies by Brahmer and colleagues,1 reviewed in this issue of The ASCO Post, has been long awaited, considering more than 15 distinct indications have been granted by the U.S. Food and Drug Administration (FDA). The ...
ASCO Clinical Practice Guideline on Managing Immune-Related Adverse Events: Next Big Step for Immune Checkpoint Inhibitors
The publication of the ASCO clinical practice guideline for the management of immune therapy–related adverse events—reviewed in this issue of The ASCO Post—represents an important next step in the incorporation of checkpoint blocking antibodies as standard cancer treatment modalities.1 The U.S....
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is also...
FDA Grants Orphan Drug Designation to CLR 131 in Rhabdomyosarcoma
The U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development recently granted Orphan Drug designation to CLR 131 for the treatment of rhabdomyosarcoma, a rare pediatric cancer. “Rhabdomyosarcoma is the most common type of tissue sarcoma in children. While...
FDA Grants Fast Track Designation to Debio 1347 for Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration
Debiopharm International SA (Debiopharm) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Debio 1347, an inhibitor of fibroblast growth factor receptors 1, 2, and 3 (FGFR1–3), for the treatment of patients with unresectable or...
Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR 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. On January 12, 2018, afatinib (Gilotrif) was approved...
Now More Than Ever, the Oncology Pharmacist Can Play a Variety of Roles on the Health-Care Team
Susannah E. Koontz, PharmD, BCOP, FHOPA, is a consultant for clinical pharmacy services, research, and education in the areas of pediatric hematology/oncology, stem cell transplantation, and cellular therapy. She has held positions at the Children’s Cancer Hospital at The University of Texas MD...
Pembrolizumab Plus Standard Chemotherapy Improves Survival in Newly Diagnosed Metastatic Non–Small Cell Lung Cancer
ADDING THE IMMUNE checkpoint inhibitor pembrolizumab (Keytruda) to standard chemotherapy with pemetrexed (Alimta) and a platinum as first-line therapy was superior to chemotherapy alone in the KEYNOTE-189 trial.1 Induction and maintenance therapies with the new triplet therapy improved overall...
FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous...
FDA Approves Daratumumab in Combination With VMP for Newly Diagnosed Patients With Multiple Myeloma Who Are Transplant-Ineligible
On May 7, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with bortezomib (Velcade), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone—VMP—for the treatment of patients with newly diagnosed multiple myeloma who are...
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 30, the U.S. Food and Drug Administration (FDA) accepted for priority review the biologics license application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who...
FDA Approves Drug Combination for Adjuvant Treatment of BRAF V600–Mutant Melanoma
On April 30, 2018, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement following...
HPV-Related Cancers Like Mine Are Avoidable, So Why Aren’t More Kids Being Vaccinated?
The latest news from the Centers for Disease Control and Prevention about vaccination rates in the United States for human papillomavirus (HPV) is disappointing. It shows that in 2016, just 43.4% of adolescents (49.5% of females and 37.5% of males) were up-to-date with the recommended 3-dose HPV...
FDA Approves Dabrafenib/Trametinib Combination for BRAF-Positive Anaplastic Thyroid Cancer
Today, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of unresectable, metastatic, BRAF V600E mutation–positive anaplastic thyroid cancer. Anaplastic thyroid cancer accounts for about 1% to 2% of all...
Role of Bone-Modifying Agents in Multiple Myeloma
As reported in the Journal of Clinical Oncology by Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma.1 The update was performed by an expert panel systematic...
Nivolumab in Adjuvant Treatment of Melanoma
On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or...
Editor’s Note: FDA Response to Comments by Dr. Steven E. Vogl
In 2011, the U.S. Food and Drug Administration (FDA) convened an advisory committee that recognized metastasis-free survival as a clinically relevant endpoint for nonmetastatic prostate cancer due to shorter trial readout times and acknowledgment that a substantial delay in the transition to a...
Should We Treat Rising PSA in Men With Castrate Androgen Levels?
In rapid succession, the SPARTAN study results were presented at the 2018 Genitourinary Cancers Symposium, the data were published in The New England Journal of Medicine,1 and the drug apalutamide -(Erleada) was approved by the U.S. Food and Drug Administration (FDA) for men with previously...
Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response
On December 22, 2017, the product label for nilotinib (Tasigna) was updated to include information on nilotinib discontinuation, postdiscontinuation monitoring, and guidance for treatment reinitiation in patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) who have...
IL-15 Superagonist Plus Nivolumab in Advanced NSCLC
In a phase Ib trial reported in The Lancet Oncology, Wrangle et al found evidence of activity of the combination of nivolumab (Opdivo) and the interleukin (IL)-15 superagonist ALT-803 in patients with previously treated advanced non–small cell lung cancer (NSCLC). ALT-803 targets the shared...
FDA 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...
