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Showing 1901 - 1950Opportunities, Issues, and Challenges for Biosimilars in Oncology
In an article in The New England Journal of Medicine, Lyman et al reviewed opportunities, issues, and challenges posed by the advent of biosimilar medications, focusing on biosimilars in cancer treatment. Although these agents could help to meet the health-care goals of high quality care with cost...
FDA Expands Approval of Pembrolizumab to Include New Lymphoma Indication
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy. KEYNOTE-170...
FDA Approves Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer Following Initial Surgery
Today, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel) followed by bevacizumab as a single agent for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection....
FDA Approves Pembrolizumab for Previously Treated Recurrent or Metastatic PD-L1–Expressing Cervical Cancer
On June 12, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cervical cancer and disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1) [Combined Positive Score...
Resources to Help You Understand What Right-to-Try Legislation Means for Practices, Patients
WITH CONGRESS having recently passed federal “right-to-try” (RTT) legislation, ASCO has developed a suite of educational resources that will help members understand the impact of this law on cancer care and individuals with cancer. Educational resources include: Podcast THE LATEST ASCO in Action...
Expert Point of View: John Heymach, MD, PhD, and Leena Gandhi, MD
“THIS STUDY represents a true milestone in the field of lung cancer. For the first time, the vast majority of patients with non–small cell lung cancer (NSCLC) can receive immunotherapy with pembrolizumab (Keytruda),” said ASCO expert John Heymach, MD, PhD, of MD Anderson Cancer Center, Houston,...
Immunotherapy Benefits Survival, Improves Safety, vs Platinum-Based Chemotherapy for PD-L1–Expressing NSCLC
IMMUNOTHERAPY WITH pembrolizumab (Keytruda) improved overall survival compared with investigator’s choice of platinum-based chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) in the KEYNOTE-042 trial. Median overall survival was improved by 4 to 8...
FDA Approves Second-Line Venetoclax for CLL or SLL With or Without 17p Deletion
On June 8, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. MURANO Approval was based ...
FDA Approves Biosimilar to Pegfilgrastim to Reduce Risk of Infection During Myelosuppressive Chemotherapy
On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive...
Dabrafenib Plus Trametinib for Thyroid Cancer, Melanoma With BRAF Mutations
On May 4, 2018, dabrafenib (Tafinlar) and trametinib (Mekinist) in combination was granted approval for treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options.1-3 Dabrafenib is not indicated for ...
2018 ASCO: Dacomitinib vs Gefitinib in Advanced NSCLC With EGFR-Activating Mutations
Overall survival (OS) data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR-activating mutations compared to gefitinib showed a median OS of 34.1 months for patients...
Adoption of Anti–PD-1 Agents Into Clinical Practice and Age Differences in Practice vs Pivotal Clinical Trials
In a retrospective cohort study reported in JAMA Oncology, O’Connor et al found that anti–programmed cell death protein 1 (PD-1) agents rapidly reached eligible patients after U.S. Food and Drug Administration (FDA) approval. The study also showed that real-world patients were...
2018 ASCO: iNNOVATE Trial Evaluates Ibrutinib in Combination With Rituximab in Patients With Waldenström's Macroglobulinemia
Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...
FDA Approves First Biosimilar to Pegfilgrastim to Help Reduce the Risk of Infection During Myelosuppressive Chemotherapy
On June 4, the U.S. Food and Drug Administration (FDA) approved pegfilgrastim-jmdb (Fulphila) as the first biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection as suggested by febrile neutropenia in patients with nonmyeloid cancer who are receiving myelosuppressive...
Aviva C. Krauss, MD, on Multiple Myeloma: Treatment Trials Analysis
Aviva C. Krauss, MD, of the U.S. Food and Drug Administration, discusses findings on an FDA analysis of immune-related adverse events and response to pembrolizumab in multiple myeloma (Abstract 8008).
FDA Statement on the Signing of the Right to Try Act
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released the following statement today: For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access...
FDA Accepts Supplemental New Drug Application for Cabozantinib in Previously Treated Advanced Hepatocellular Carcinoma
On May 29, the U.S. Food and Drug Administration (FDA) accepted for filing the supplemental new drug application (sNDA) for cabozantinib (Cabometyx) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The filing has been assigned a Prescription Drug...
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) and granted Priority Review for larotrectinib in the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. ...
FDA Grants Priority Review to Gilteritinib for the Treatment of Relapsed or Refractory FLT3 Mutation–Positive AML
The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, as detected by an FDA-approved test....
FDA Grants Orphan Drug Designation to Galinpepimut-S for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to galinpepimut-S for the treatment of multiple myeloma. The drug is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor...
FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018
Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications. EPOETIN ALFA-EPBX (RETACRIT)...
FDA Identifies Efficacy Issue in Clinical Trials of Pembrolizumab or Atezolizumab as Monotherapy in Urothelial Cancer With Low Expression of PD-L1
On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...
Logistics of CAR T-Cell Therapy in Real-World Practice
With the U.S. Food and Drug Administration (FDA) approvals of tisagenlecleucel (Kymriah)1 and axicabtagene ciloleucel (Yescarta),2 chimeric antigen receptor (CAR) T-cell therapy has moved into real-world practice, offering new potentially curative options for incurable hematologic malignancies. Its ...
PARP Inhibitor Shows Promise in Patients With BRCA-Mutated Pancreatic Cancer
A targeted therapy that has been effective in fighting ovarian cancer in women, including those with BRCA1 and BRCA2 mutations, may also help patients with aggressive pancreatic cancer who harbor these mutations and have few or no other treatment options. An international team of researchers was...
ASCO Honors Leaders in Cancer Care With 2018 Special Awards
ASCO AND ASCO’s Conquer Cancer Foundation recognized winners of ASCO’s 2018 Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards during the 2018 ASCO Annual Meeting, June 1 to June 4, in Chicago. The recipients of these awards included researchers, patient advocates, and...
Tisagenlecleucel 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...
