In the Clinic
Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
Matthew Stenger
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 ac...
Gefitinib in EGFR-Mutant Metastatic NSCLC
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 13, 2015, gefitinib (Iressa) was approved for first-line ...
Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, carfilzomib (Kyprolis) was granted accele...
Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer
Matthew Stenger
ON DECEMBER 14, 2018, trastuzumab-pkrb (Herzuma) was approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer.1 Trastuzumab-pkrb is indicated for adjuvant treatment of HER2-overexpressing breast cancer and metastatic HER2-overexpressing breast cancer.2 Health-care ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
Matthew Stenger
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 18, 2017, the chimeric antigen receptor (CAR) ...
Copanlisib in Relapsed Follicular Lymphoma
Matthew Stenger
On September 14, 2017, copanlisib (Aliqopa) was granted accelerated approval for treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on durable responses observed in a multicenter phas...
Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer
Matthew Stenger
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 tr...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
Matthew Stenger
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. Foo...
Selinexor in Relapsed or Refractory Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel hematology and 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 3, 2019, the oral nuclear export i...
Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 23, 2015, nivolumab (Opdivo) was approved for use in...
Regorafenib, Multikinase Inhibitor, for Previously Treated Metastatic Colorectal Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 27, 2012, regorafenib (Stivarga) was appro...
New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Cetuximab (Erbitux) was recently approved by the FDA for use in com...
Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC
Matthew Stenger
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. In April 2018, osimertinib (Tagrisso) was approved for th...
Neratinib Combined With Capecitabine in Previously Treated Advanced HER2-Positive Breast Cancer
Matthew Stenger
On February 25, 2020, neratinib (Nerlynx) was approved for use in combination with capecitabine for treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting.1,2 Supporting Efficacy Data...
Entrectinib for NTRK-Positive Solid Tumors and ROS1-Positive Lung Cancer
Matthew Stenger
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 August 15, 2019, the oral TRK, ROS1, and ALK kinase in...
Pembrolizumab in Metastatic Small Cell Lung Cancer
Matthew Stenger
On June 17, 2019, pembrolizumab was granted accelerated approval for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.1,2 Supporting Efficacy Data Approval was based...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Matthew Stenger
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocr...
Elotuzumab in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 30, 2015, elotuzumab (Empliciti) was approved for u...
Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers
Matthew Stenger
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its first-in-cl...
Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
Matthew Stenger
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 13, 2018, enzalutamide (Xtandi) was approved for ...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
Matthew Stenger
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. This past June, encorafenib (Braftovi) and binimetinib (M...
Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
Matthew Stenger
On July 17, 2017, neratinib (Nerlynx) a dual inhibitor of HER2 and epidermal growth factor receptor (EGFR), was approved for extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab (Herceptin)-based therapy.1,2 Supporting Effi...
Trastuzumab-dkst Approved as Biosimilar to Trastuzumab
Matthew Stenger
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 December 1, 2017, trastuzumab-dkst (Ogivri) was approv...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
Matthew Stenger
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL tri...
Daratumumab in Previously Treated Multiple Myeloma
Matthew Stenger
On November 21, 2016, daratumumab (Darzalex) was approved for use in combination with lenalidomide (Revlimid) and dexamethasone or with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.1,2 The drug was initially...
Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 2, 2015, rolapitant (Varubi) was approved for use in c...
Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 24, 2015, carfilzomib (Kyprolis) was approved for use in...
Dinutuximab in Pediatric High-Risk Neuroblastoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On March 10, 2015, the chimeric monoclonal antibody dinutuximab ...
Sunitinib and Everolimus: New Indications in Pancreatic Neuroendocrine Tumors
Matthew Stenger
With In the Clinic, The ASCO Post provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Sunitinib Indication—The oral kinase inhibitor...
Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
Matthew Stenger
On August 8, 2018, the CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody mogamulizumab-kpkc (Poteligeo) was approved for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.1,2 Supporting Efficacy Data The current...
Brentuximab Vedotin for Consolidation Therapy in High-Risk Hodgkin Lymphoma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 17, 2015, brentuximab vedotin (Adcetris) was approved ...
Lenvatinib in Advanced Radioiodine-Refractory Differentiated Thyroid Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On February 13, 2015, lenvatinib (Lenvima) was approved for the ...
Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma
Matthew Stenger
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 31, 2020, tafasitamab-cxix, a CD19-directed cytol...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
Matthew Stenger
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 grante...
Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma
Matthew Stenger
In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on t...
Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC
Matthew Stenger
On June 22, 2017, regular approvals were granted to dabrafenib (Tafinlar) and trametinib (Mekinist) given in combination for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test.1-...
Carfilzomib Plus Dexamethasone in Previously Treated Multiple Myeloma
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 21, 2016, carfilzomib (Kyprolis) was approved for use in...
Ado-Trastuzumab Emtansine in Metastatic Breast Cancer
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On February 22, 2013, ado-trastuzumab emtansine (Kadcy...
Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Matthew Stenger
On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov id...
Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned...
Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy
Matthew Stenger
On June 8, 2018, venetoclax (Venclexta) was granted regular approval for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED o...
Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma
Matthew Stenger
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 (Yer...
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
Matthew Stenger
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy ...
Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 28, 2014, an oral suspension of mercaptopurine (Purixan...
Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer
Matthew Stenger
Indication Crizotinib (Xalkori) is an oral inhibitor of receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-Met), and recepteur d’origine nantais (RON). In August 2011, the FDA granted the drug accelerated approval for the treatment of pa...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
Matthew Stenger
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel onc...
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Matthew Stenger
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2 S...
Olaparib as Maintenance Therapy for Germline BRCA-Mutated Metastatic Pancreatic Adenocarcinoma
Matthew Stenger
On December 27, 2019, the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib was approved for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma, as detected by a U.S. Food and Drug Administration (FDA)...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Matthew Stenger
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
Matthew Stenger
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2017, the programmed cell death ligand 1 (PD-L1) inhib...
