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Showing 1901 - 1950FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung...
FDA Grants Orphan Drug Designation to CPI-613 for Treatment of Burkitt Lymphoma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of Burkitt lymphoma. Burkitt lymphoma is a highly aggressive hematologic B-cell malignancy classically characterized by the overexpression of c-Myc. Due to the rapid proliferation rate of...
Excerpt From the 2018 ASCO Presidential Address: ‘Delivering Discoveries: Expanding the Reach of Precision Medicine’
In my area of research, lung cancer, precision medicine is indeed transforming the treatment of this disease and has important implications for other cancers and for the future of our patients with cancer. Today’s achievement of being able to systematically identify genomic changes that can be...
Outcomes in Patients With Melanoma Treated With Anti–PD-1 Antibody Beyond Disease Progression
A POOLED analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond disease progression on Response Evaluation Criteria in Solid Tumors (RECIST) in some patients receiving anti–programmed cell death protein 1 (anti–PD-1) antibodies for unresectable or...
Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
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. Earlier this year, apalutamide (Erleada) was approved for ...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK...
FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML
The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...
IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb
The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
FDA Takes Steps to Foster Greater Efficiency in Biosimilar Development by Reconsidering Draft Guidance on Evaluating Analytical Studies
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped. I believe that the US Food and Drug Administration (FDA) can do more to support the development of biosimilars, as well as...
FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...
FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...
FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer
ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...
Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer
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 who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...
I’m Proud to Have Contributed to the FDA Approval of CAR T-Cell Therapy
When I was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2013, I used to joke that if I had to get cancer, this wasn’t a bad one to have. At just 32, I was otherwise healthy, and my prognosis for a cure was good, according to my oncologist. So I felt confident that once I underwent...
FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9). The application is seeking approval for an expanded age...
Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for ...
EHA 2018: Tisagenlecleucel Demonstrates More Than 1-Year Durability of Response in Adults With Relapsed or Refractory DLBCL
Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...
FDA Clears Expanded Indication of Scalp-Cooling System
Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as...
FDA and EMA Accept Regulatory Submissions for Review of Talazoparib for Patients With Germline BRCA-Mutated Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted Priority Review designation a new drug application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib vs chemotherapy in patients with germline BRCA-mutated,...
Opportunities, 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...
