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Showing 51 - 100Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes
On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...
FDA Approves Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy...
FDA Approves Pomalidomide for Kaposi Sarcoma
On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy and those with Kaposi...
AACR 2020: Triplet Regimen Improves Progression-Free Survival in Advanced Melanoma in IMspire150 Trial
The addition of the checkpoint inhibitor atezolizumab to two targeted therapies (the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib) as initial therapy improved outcomes compared with the two targeted therapies plus placebo in patients with newly diagnosed BRAF V600E/K–mutant advanced ...
FDA Approves Niraparib as Maintenance Therapy for Advanced Ovarian Cancer
On April 29, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy....
Phase III HER2CLIMB Trial Yields Positive Data in Patients With HER2-Positive Metastatic Breast Cancer and Brain Metastasis
The investigational oral agent tucatinib added to trastuzumab/capecitabine reduced the risk of death by one-third and reduced the risk of disease progression or death by one-half in patients with heavily pretreated metastatic HER2-positive breast cancer, including those with untreated or previously ...
Tucatinib Combination Extends Survival in HER2-Positive Metastatic Breast Cancer, Including Patients With Brain Metastases
For patients with progressing HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1), no single regimen is an established standard of care. More than 50% of these patients will develop brain metastasis, and thus far, treatments...
Pembrolizumab in Adjuvant Treatment of Melanoma With Involvement of Lymph Nodes After Complete Resection
In early 2019, pembrolizumab was approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.1,2 Supporting Efficacy Data Approval was based on findings in the double-blind EORTC 1325/KEYNOTE-054 trial (ClinicalTrials.gov identifier...
First-Line Pembrolizumab Plus Axitinib for Advanced Renal Cell Carcinoma
On April 19, 2019, pembrolizumab was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III...
Immunotherapy Strategies in Renal Cell Carcinoma: Present and Future
Immunotherapy with checkpoint inhibitors is now considered a standard of care for the front-line treatment of advanced renal cell carcinoma. Despite better outcomes with these agents, there is still room for improvement. At the 2019 Chemotherapy Foundation Symposium, Robert J. Motzer, MD, of...
Barry Paul Sleckman, MD, PhD, to Lead O’Neal Comprehensive Cancer Center
Barry Paul Sleckman, MD, PhD, a well-known cancer researcher who focuses on understanding how DNA double-strand breaks are generated and repaired—a key topic for cancer and immune system development and function—has been named Director of the O’Neal Comprehensive Cancer Center at the University of ...
CheckMate 214: Nivolumab/Ipilimumab vs Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma
As reported in The Lancet Oncology by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown maintained survival benefit of first-line nivolumab/ipilimumab vs sunitinib among patients with...
Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer
EARLIER THIS YEAR, atezolizumab was granted accelerated approval in combination with nab-paclitaxel in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express programmed cell death ligand 1 (PD-L1–stained tumor-infiltrating...
ESMO 2019: LIBRETTO-001 Trial of Selpercatinib in RET Fusion–Positive Thyroid Cancer
Patients with advanced RET fusion–positive thyroid cancer and RET-mutant medullary thyroid cancer had high rates of response following treatment with selpercatinib, according to findings from the phase I/II LIBRETTO-001 trial presented by Wirth et al at the European Society for Medical Oncology...
ESMO 2019: ASCEND-7: Ceritinib for Patients With ALK-Positive NSCLC Metastatic to the Brain
Patients with ALK-positive non–small cell lung cancer (NSCLC) that was metastatic to the brain at baseline demonstrated whole-body, intracranial, and extracranial responses following treatment with ceritinib, according to findings from the phase II ASCEND-7 study presented by Chow et al at the...
Adjuvant Treatment With Ado-trastuzumab Emtansine in HER2-Positive Early Breast 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, ado-trastuzumab emtansine (T-DM1) was...
WCLC 2019: Selpercatinib in RET Fusion–Positive NSCLC
Patients with RET fusion–positive non–small cell lung cancer (NSCLC) comprise up to 2% of all NSCLC cases, but there are no targeted therapies currently approved for patients with this form of lung cancer. Selpercatinib (also known as LOXO-292) is an oral and highly selective investigational drug...
What Causes Liver Injury During Treatment With Pembrolizumab
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first...
What Causes Liver Injury During Treatment With Pembrolizumab
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
Atezolizumab Plus Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Lung Cancer
In late 2018, atezolizumab was approved for use in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberration.1,2 Supporting Efficacy Data Approval was ...
Pembrolizumab for Advanced Merkel Cell Carcinoma
Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, atezolizumab was approved for use in combination with carboplatin and etoposide in the first-line treatment of adult patients with extensive-stage small cell lung cance (SCLC).1,2 Supporting Efficacy Data Approval was based on findings in the phase III double-blind IMpower133...
What Causes Liver Injury During Treatment With Pembrolizumab?
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a...
What Causes Liver Injury During Treatment With Pembrolizumab?
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
Adjuvant Trastuzumab Emtansine vs Standard Trastuzumab in Residual HER2-Positive Breast Cancer After Neoadjuvant Therapy
In the phase III KATHERINE trial reported in The New England Journal of Medicine,1Gunter von Minckwitz, MD, of the German Breast Group, Neu-Isenburg, and colleagues found that adjuvant treatment with the antibody-drug conjugate trastuzumab emtansine (T-DM1) improved invasive disease–free survival...
Pembrolizumab in Combination With Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC
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 October 30, 2018, pembrolizumab in combination with...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
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 November 26, 2018, larotrectinib (Vitrakvi) was...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular 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 September 24, 2018, duvelisib (Copiktra) was granted...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
Nivolumab for Third-Line Treatment of Metastatic Small Cell Lung Cancer
ON AUGUST 16, 2018, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression after platinum-based chemotherapy and at least one other line of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib. KEYNOTE-224 Approval was based on KEYNOTE-224, a single-arm,...
Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase
Earlier in 2018, nilotinib (Tasigna) was approved for the treatment of pediatric patients aged ≥ 1 year with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) or Philadelphia chromosome–positive CML-CP resistant or intolerant to prior tyrosine...
Three Scientists Recognized With Awards for Distinguished Research in Tumor Immunology
The Cancer Research Institute honored three scientists for their work in immunology and cancer immunotherapy at the group’s annual gala held recently in New York. Padmanee Sharma, MD, PhD, Professor of Genitourinary Medical Oncology and Immunology at The University of Texas MD Anderson Cancer...
Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell 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 April 16, 2018, nivolumab (Opdivo) and ipilimumab...
Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
IN APRIL 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib (Rubraca) was granted approval for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2...
Abiraterone Acetate Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
IN EARLY 2018, abiraterone acetate tablets (Yonsa, Zytiga) in combination with prednisone was approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS BASED on findings from the phase III LATITUDE trial, in which 1,199...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....
Pembrolizumab in Relapsed or Refractory Primary Mediastinal 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 June 13, 2018, pembrolizumab (Keytruda) was granted...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast 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. On July 18, 2018, the indication for ribociclib (Kisqali) ...
Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer
On July 10, 2018, ipilimumab (Yervoy) was granted accelerated approval for use in combination with nivolumab (Opdivo) for the treatment of patients at least 12 years of age with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer progressing...
Immunotherapy Combination in Melanoma Brain Metastases
In the phase II CheckMate 204 study reported in The New England Journal of Medicine, Tawbi et al found that combined nivolumab (Opdivo) and ipilimumab (Yervoy) produced a high rate of intracranial clinical benefit in patients with melanoma brain metastases. Study Details The study included 94...
Immunotherapy in Advanced Esophagogastric Cancer
As reported in the Journal of Clinical Oncology by Janjigian et al, the phase I/II CheckMate-032 study has shown activity of nivolumab (Opdivo) and nivolumab plus ipilimumab (Yervoy) in advanced esophagogastric cancer. In the esophagogastric cohort of the multicohort study, 160 patients (who...
Durvalumab After Chemoradiation in Unresectable Stage III NSCLC
Early in 2018, durvalumab (Imfinzi) was approved for the treatment of unresectable stage III non–small cell lung cancer (NSCLC) that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.1,2 Supporting Efficacy Data Approval was based on a planned interim...
Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings in ...
No Benefit of Adding Abiraterone to Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Increasing PSA
The PLATO trial failed to show benefit of adding abiraterone (Zytiga)/prednisone to ongoing enzalutamide (Xtandi) vs abiraterone/prednisone in men with metastatic castration-resistant prostate cancer exhibiting rising prostate-specific antigen (PSA) during enzalutamide treatment. Results of the...
Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
