Search Results
Your search for ,Fda matches 3753 pages
Showing 2151 - 2200FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
FDA Authorizes MSK-IMPACT Tumor Profiling Assay
Today, the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s MSK-IMPACT tumor profiling assay, an in vitro diagnostic test that can identify more biomarkers that may be found in various cancers than any test previously reviewed by the...
Ventana MMR IHC Panel for Patients Diagnosed With Colorectal Cancer Receives FDA Clearance
On November 14, the U.S. Food & Drug Administration (FDA) granted clearance to the Ventana MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect proteins associated with the DNA...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy. ALCANZA...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of...
Immunotherapeutic Approaches for B-Cell Acute Lymphocytic Leukemia
New therapeutic agents for acute lymphocytic leukemia (ALL) have led to dramatic improvement in remission rates, but questions concerning the proper sequencing and combination of these agents remain. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic...
FDA Approves Novel Therapies for Lymphoma Indications
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
FDA Approves New Treatment for Adults With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to acalabrutinib (Calquence) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard...
AACR-NCI-EORTC: Rising Number of Seamless Clinical Trials in Oncology
The number of early-phase trials in oncology that adopted a seamless approach—as opposed to a traditional trial approach with defined phase I, II, and III plans—is rising, with data from the majority of them presented after 2014, according to a study presented by Barata et al at the...
FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma...
New Biosimilar Educational Materials for Health-Care Professionals From the FDA
The U.S. Food and Drug Administration (FDA) has announced the release of new educational materials for health-care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of...
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
FDA Approves Intravenous Rolapitant for Delayed Chemotherapy-Induced Nausea and Vomiting
On October 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
CELESTIAL Trial: Cabozantinib Meets Primary Endpoint of Overall Survival in Patients With Advanced Hepatocellular Carcinoma
On October 16, Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib (Cabometyx) providing a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with...
FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, HER2-negative...
Register for December 1 FDA Workshop on Cardiovascular Toxicities in Immunotherapy Trials
THE U.S. FOOD & DRUG ADMINISTRATION (FDA) and the Oncology Center of Excellence (OCE) will host a complimentary public workshop, Assessment of Cardiovascular Toxicities in Immuno-Oncology Trials, on December 1. ASCO is supporting the workshop with the American College of Cardiology (ACC), the...
FDA Accepts sBLA for Durvalumab in Locally Advanced Unresectable NSCLC
On October 17, the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with locally advanced (stage III) unresectable non–small cell lung cancer (NSCLC) whose disease has not progressed ...
FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
For HPV Vaccine to Have Optimal Impact, ‘Provider Hesitancy’ Must Be Overcome
Honoring National Cancer Institute researchers Douglas R. Lowy, MD, and John T. Schiller, PhD, with the Lasker-DeBakey Clinical Medical Research Award for advances in technology that enabled the development of human papillomavirus (HPV) vaccines to prevent cervical cancer and other tumors caused by ...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
Second-Line Pembrolizumab Extends Survival in Urothelial Cancer
PEMBROLIZUMAB (KEYTRUDA) extended survival by about 3 months in patients with advanced urothelial cancer whose disease progressed on platinum-based chemotherapy vs investigator’s choice of therapy, according to the mature results of the KEYNOTE-045 trial presented at the European Society for...
FDA Approves CAR T-Cell Therapy to Treat Adults With Certain Types of Large B-Cell Lymphoma
On October 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non–Small Cell Lung Cancer
At the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan, Pfizer announced full results from the phase II clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib. The agent exhibited clinically...
FDA Clears 7T Magnetic Resonance Imaging Device
On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in...
FDA Grants Priority Review for Abemaciclib as Initial Treatment of Advanced Breast Cancer
On October 12, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its New Drug Application (NDA) for abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor. MONARCH 3 The NDA was based upon the positive interim...
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
Immunotherapy for Metastatic Mismatch Repair–Deficient Colorectal Cancer: Game-Changer for Small Group of Patients
PATIENTS WITH DNA mismatch repair–deficient (dMMR) metastatic colorectal cancer display a high level of microsatellite instability (MSI-H)1 and demonstrate poor chemosensitivity and shorter overall survival than patients with mismatch repair–proficient (pMMR) metastatic metastatic colorectal...
FDA Grants Accelerated Approval to Nivolumab for Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 APPROVAL WAS BASED on a 154-patient subgroup of ...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
FDA Approves Copanlisib for Relapsed Follicular Lymphoma
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Can We Have a Successful Vaccine Against Cancer?
EARLY IN our careers, few of us imagined that a vaccine could one day prevent cancer. Now, there is a vaccine that keeps the risks from human papillomavirus (HPV) at bay, and yet universal adoption of the HPV vaccine has been incomplete. As a result of misinformation about the vaccine—and its...
FDA Conducts Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
FDA Grants Priority Review for Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer
On September 29, Roche announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as ...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
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 9, 2017, avelumab (Bavencio) was granted...
Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and 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 June 22, 2017, the combination of rituximab (Rituxan)...
FDA Expands Approval of Ipilimumab to Pediatric Patients 12 Years and Older
On July 24, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use now to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of...
