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Showing 801 - 850FDA Grants Accelerated Approval to Mobocertinib for Patients With Metastatic NSCLC and EGFR Exon 20 Insertion Mutations
� On September 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has...
Recent FDA Approvals in Endometrial Cancer
In recent months, the U.S. Food and Drug Administration approved two treatment options for patients with endometrial cancer, which are summarized herein. Dostarlimab-gxly for dMMR Endometrial Cancer On April 22, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adult...
With the Exception of Cervical Cancer, HPV-Associated Cancers Are on the Rise, Especially in Older Adults
Although the incidence of cervical cancer has decreased 1.03% a year over the past 17 years in the United States, likely due to screening or vaccination, other human papillomavirus (HPV)-associated cancers are increasing in both men and women, according to a study by Cheng-I Liao, MD, currently of...
Gynecologic Cancers 2020–2021 Almanac
The past year has been a remarkable and noteworthy time with much exciting progress made in gynecologic cancers, despite the underlying presence of the COVID-19 pandemic. Several key studies were presented in 2020–2021 that detailed the results of novel therapies for our patients with cervical,...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer
The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...
FDA Grants Zanubrutinib Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma
On September 15, zanubrutinib (Brukinsa), a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least...
Novel Monoclonal Antibody Emerges as Potential First-Line Standard in Nasopharyngeal Cancer
A new first-line standard of care may be emerging for recurrent or metastatic nasopharyngeal carcinoma, based on the findings of the global phase III JUPITER-02 trial presented at the 2021 ASCO Annual Meeting by investigators from China.1 In the study, toripalimab, an anti–PD-1 monoclonal antibody, ...
Maintenance Durvalumab: Increased Utilization Could Improve NSCLC Outcomes
Maintenance durvalumab—the recommended maintenance treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC) following chemoradiation—remains significantly underutilized, according to research presented by Liu et al at the International Association for the Study of Lung...
Novel Urine-Based Test Evaluated in Prostate Cancer Detection and Risk Stratification
In a validation study with data presented at the American Urological Association’s 2021 Annual Meeting, clinician-researchers reported that a new test (miR Sentinel PCC4 Test) may be able to detect and risk-classify prostate cancer at the molecular level with predictive accuracy based on a single...
Racial Disparities Among Men With Prostate Cancer
Despite great strides in prostate cancer treatment over the past several years, racial disparities in care persist, according to new data presented during the 2021 Annual Meeting of the American Urological Association (AUA). Three studies highlighting this topic were presented during a virtual...
Amivantamab-vmjw for Previously Treated Advanced NSCLC With EGFR Mutation
On May 21, 2021, amivantamab-vmjw, a bispecific antibody directed against EGFR and MET receptors, was granted accelerated approval for treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and...
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...
Dana-Farber Cancer Institute Establishes the David Liposarcoma Research Initiative
Dana-Farber Cancer Institute announced that The Rossy Foundation has committed $10 million to establish the David Liposarcoma Research Initiative. The 5-year initiative will conduct groundbreaking research into liposarcoma at Dana-Farber and external collaborating partner institutions, with the aim ...
Assumptions, Data … and More Questions!
I read with great interest the results from the phase II ZUMA-12 study of axicabtagene ciloleucel, presented during the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 But the results raised several questions for me. Axicabtagene ciloleucel, an autologous anti-CD19...
FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia
On August 31, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa), a Bruton’s tyrosine kinase inhibitor, for adult patients with Waldenström’s macroglobulinemia. ASPEN Trial Zanubrutinib was investigated in ASPEN (ClinicalTrials.gov identifier: NCT03053440), a randomized,...
FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma
On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...
Prostate Cancer Diagnostics: Novel Approaches Are Leaving Conventional Imaging Behind
Advances in molecular imaging are having a big impact on prostate cancer management and outcomes, according to Ashesh B. Jani, MD, the James C. Kennedy Professor in Prostate Cancer, Department of Radiation Oncology at the Winship Cancer Institute of Emory University, Atlanta. Dr. Jani described his ...
Update to NCCN: Cancer and COVID-19 Vaccination Guidance Announced
Today, the National Comprehensive Cancer Network® (NCCN®) announced significant updates to the NCCN: Cancer and COVID-19 Vaccination guidance. This is the fourth version of NCCN’s COVID-19 vaccination guide and incorporates the latest data plus recent approvals from the U.S. Food and Drug...
Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer
Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast...
Recent FDA Approvals in dMMR Solid Tumors and von Hippel Lindau–Associated Cancers
This week, we’ll be reviewing two recent FDA approvals in the oncology space, for patients with mismatch repair–deficient, or dMMR, recurrent or advanced solid tumors, and for adult patients with cancers associated with von Hippel-Lindau disease.
FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma
On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...
FDA Pipeline: Reviews for Agents in Acute Graft-vs-Host Disease, Nasopharyngeal and Ovarian Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to an agent for the prevention of acute graft-vs-host disease; Breakthrough Therapy designation to an anti–PD-1 monoclonal antibody for the treatment of metastatic nasopharyngeal carcinoma; and Fast Track designation to a ...
PD-L1–Positive Non–Small Cell Lung Cancer
In this video, Drs. Justin F. Gainor, Ibiayi Dagogo-Jack, and Jyoti D. Patel discuss current therapy options for PD-L1–positive non–small cell lung cancer (NSCLC). Dr. Gainor presents the case of a 65-year-old man with 55-year smoking history who was diagnosed with stage II NSCLC. The faculty...
NTRK Fusion–Positive Non–Small Cell Lung Cancer
In this video, Drs. Justin F. Gainor, Ibiayi Dagogo-Jack, and Jyoti D. Patel discuss the management of NTRK fusion–positive non–small cell lung cancer (NSCLC). Dr. Gainor presents the case of a 44-year-old man with a 5 pack-year history of tobacco exposure who was diagnosed with metastatic NSCLC;...
FDA Grants Approval to the Pfizer-BioNTech COVID-19 Vaccine
On August 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals aged 16 years and older. The vaccine also...
Caution With Robotically Assisted Surgical Devices for Mastectomy: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is reminding patients and health-care providers that the safety and effectiveness of robotically assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA...
FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors
On August 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, who have had disease...
FDA Approves Belzutifan for Cancers Associated With von Hippel-Lindau Disease
On August 13, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg), a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or...
FDA Pipeline: Reviews for Agents in Lung Cancer, Thyroid Cancer, Kidney Cancer, and More
Recently, the U.S. Food and Drug Administration (FDA) accepted applications for agents aiming to treat non–small cell lung cancer (NSCLC), differentiated thyroid cancer, renal cell carcinoma (RCC), hypersensitive acute lymphoblastic leukemia (ALL), mucosal melanoma, and endometrial carcinoma....
FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma
On August 10, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). CLEAR Trial The efficacy of this combination was investigated in CLEAR...
Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
On June 30, 2021, asparaginase erwinia chrysanthemi (recombinant)-rywn was approved as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed...
CAR T-Cell Gene Therapy in Non-Hodgkin Lymphomas
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel gene therapies for resistant non-Hodgkin lymphomas (NHL), including...
A New Era of Hope for Patients With Triple-Negative Breast Cancer
Triple-negative breast cancer is a particularly devastating subtype of breast cancer, as it is often diagnosed in young women and is associated with an exceptionally poor prognosis. The “triple-negative” designation indicates that the three key features driving most breast cancers (estrogen...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the pivotal phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III...
FDA Alert: Clinical Trial Results Show an Increased Risk of Death Associated With Melphalan Flufenamide
The U.S. Food and Drug Administration (FDA) is alerting patients and health-care professionals that a clinical trial (OCEAN, Study OP-103; ClinicalTrials.gov identifier: NCT03151811) evaluating melphalan flufenamide with dexamethasone to treat patients with multiple myeloma showed an increased risk ...
FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage Triple-Negative Breast Cancer
On July 26, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. The FDA also...
Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, 2021, lorlatinib was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ALK-positive tumors as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA simultaneously approved the Ventana ALK (D5F3) CDx Assay ...
Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma
On March 22, 2021, pembrolizumab was approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 cm above the gastroesophageal junction) carcinoma who...
Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, 2021, the VEGF tyrosine kinase inhibitor tivozanib was approved for treatment of adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on findings in the open-label, phase III...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Endometrial Cancer
On April 22, 2021, the PD-1 inhibitor dostarlimab-gxly was granted accelerated approval for treatment of adults with mismatch repair–deficient recurrent or advanced endometrial cancer, as determined by a U.S. Food and Drug Administration (FDA)-approved test, that has progressed on or following a...
Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, 2021, the CD19-directed genetically modified autologous T-cell immunotherapy axicabtagene ciloleucel was granted accelerated approval for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1,2 Axicabtagene ciloleucel is...
Avapritinib for Advanced Systemic Mastocytosis
On June 16, 2021, avapritinib was approved for the treatment of adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.1,2 Avapritinib is not recommended...
Role of PI3K Inhibition in Indolent Lymphomas
As reported by Fowler et al in the Journal of Clinical Oncology1—and summarized in this issue of The ASCO Post—the international phase IIb UNITY-NHL trial of 208 patients with marginal zone lymphoma (MZL; n = 69), follicular lymphoma (FL; n = 117), and small lymphocytic lymphoma (SLL; n = 22)...
Expert Point of View: Clifford Goodman, PhD
Moderator of the session at the National Comprehensive Cancer Network Virtual Oncology Policy Summit, Clifford Goodman, PhD, Senior Vice President at The Lewin Group, said he was struck by the diverse impacts that the COVID-19 pandemic had on cancer care. One area that remained relatively...
FDA Pipeline: Designations for Therapies in Myelodysplastic Syndromes and Triple-Negative Breast Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted special designation status to treatments for myelodysplastic syndromes and advanced triple-negative breast cancer. Breakthrough Therapy Designation for Venetoclax in Combination With Azacitidine for Myelodysplastic Syndromes Venetoclax...
Pembrolizumab/Lenvatinib Granted Regular Approval for Advanced Endometrial Carcinoma
On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR). These patients must have ...
