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In the Clinic

Hematologic Malignancies
Lymphoma
Immunotherapy

Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma

Matthew Stenger  /  September 25, 2018

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...

Lung Cancer

Gefitinib in EGFR-Mutant Metastatic NSCLC

Matthew Stenger  /  August 25, 2015

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 ...

Multiple Myeloma

Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma

Matthew Stenger  /  September 1, 2012

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...

Breast Cancer

Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer

Matthew Stenger  /  March 25, 2019

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 ...

Hematologic Malignancies
Lymphoma

Axicabtagene Ciloleucel for Large B-Cell Lymphoma

Matthew Stenger  /  November 25, 2017

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) ...

Hematologic Malignancies
Lymphoma

Copanlisib in Relapsed Follicular Lymphoma

Matthew Stenger  /  November 25, 2017

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...

Lung Cancer

Atezolizumab Combined With Chemotherapy in First-Line Extensive-Stage Small Cell Lung Cancer

Matthew Stenger  /  August 10, 2019

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...

Gynecologic Cancers
Immunotherapy

Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy

Matthew Stenger  /  September 25, 2018

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...

Multiple Myeloma

Selinexor in Relapsed or Refractory Multiple Myeloma

Matthew Stenger  /  August 25, 2019

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...

Kidney Cancer

Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy

Matthew Stenger  /  December 25, 2015

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  /  November 15, 2012

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...

Head and Neck Cancer

New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck

Matthew Stenger  /  January 1, 2012

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...

Lung Cancer

Osimertinib in First-Line Treatment of EGFR-Mutant Metastatic NSCLC

Matthew Stenger  /  October 10, 2018

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...

Breast Cancer

Neratinib Combined With Capecitabine in Previously Treated Advanced HER2-Positive Breast Cancer

Matthew Stenger  /  March 25, 2020

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...

Lung Cancer

Entrectinib for NTRK-Positive Solid Tumors and ROS1-Positive Lung Cancer

Matthew Stenger  /  October 10, 2019

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...

Lung Cancer

Pembrolizumab in Metastatic Small Cell Lung Cancer

Matthew Stenger  /  August 10, 2019

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...

Solid Tumors
Breast Cancer

Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer

Matthew Stenger  /  November 25, 2017

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...

Multiple Myeloma

Elotuzumab in Previously Treated Multiple Myeloma

Matthew Stenger  /  January 25, 2016

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...

Skin Cancer

Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers

Matthew Stenger  /  December 15, 2011

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...

Prostate Cancer

Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  August 25, 2018

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 ...

Skin Cancer

Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations

Matthew Stenger  /  August 10, 2018

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...

Solid Tumors
Breast Cancer

Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Matthew Stenger  /  November 25, 2017

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...

Solid Tumors
Immunotherapy

Trastuzumab-dkst Approved as Biosimilar to Trastuzumab

Matthew Stenger  /  January 25, 2018

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...

Leukemia

Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL

Matthew Stenger  /  September 25, 2017

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...

Multiple Myeloma

Daratumumab in Previously Treated Multiple Myeloma

Matthew Stenger  /  December 10, 2016

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...

Symptom Management

Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting

Matthew Stenger  /  September 25, 2015

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...

Multiple Myeloma

Carfilzomib in Combination With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

Matthew Stenger  /  August 25, 2015

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...

CNS Cancers

Dinutuximab in Pediatric High-Risk Neuroblastoma

Matthew Stenger  /  April 10, 2015

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 ...

Solid Tumors

Sunitinib and Everolimus: New Indications in Pancreatic Neuroendocrine Tumors

Matthew Stenger  /  November 15, 2011

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...

Hematologic Malignancies
Lymphoma

Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

Matthew Stenger  /  October 10, 2018

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...

Lymphoma

Brentuximab Vedotin for Consolidation Therapy in High-Risk Hodgkin Lymphoma

Matthew Stenger  /  September 10, 2015

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 ...

Thyroid Cancer

Lenvatinib in Advanced Radioiodine-Refractory Differentiated Thyroid Cancer

Matthew Stenger  /  March 10, 2015

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 ...

Lymphoma
Immunotherapy

Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma

Matthew Stenger  /  August 25, 2020

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...

Solid Tumors

Larotrectinib for Solid Tumors With NTRK Gene Fusions

Matthew Stenger  /  December 25, 2018

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...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Matthew Stenger  /  August 25, 2018

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...

Solid Tumors
Lung Cancer

Dabrafenib and Trametinib in BRAF V600E–Mutant Metastatic NSCLC

Matthew Stenger  /  November 25, 2017

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-...

Hematologic Malignancies
Multiple Myeloma

Carfilzomib Plus Dexamethasone in Previously Treated Multiple Myeloma

Matthew Stenger  /  March 10, 2016

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...

Breast Cancer

Ado-Trastuzumab Emtansine in Metastatic Breast Cancer 

Matthew Stenger  /  April 15, 2013

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...

Leukemia
Lymphoma

Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Matthew Stenger  /  November 10, 2019

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...

Prostate Cancer

Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  August 25, 2019

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...

Leukemia
Lymphoma

Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy

Matthew Stenger  /  November 10, 2018

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...

Solid Tumors
Kidney Cancer

Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma

Matthew Stenger  /  October 25, 2018

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...

Solid Tumors
Lung Cancer

Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer

Matthew Stenger  /  November 25, 2017

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 ...

Leukemia

Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia

Matthew Stenger  /  June 10, 2014

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...

Lung Cancer

Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer

Matthew Stenger  /  November 1, 2011

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...

Skin Cancer

Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma

Matthew Stenger  /  October 15, 2011

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...

Prostate Cancer

Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Matthew Stenger  /  July 10, 2020

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...

Pancreatic Cancer

Olaparib as Maintenance Therapy for Germline BRCA-Mutated Metastatic Pancreatic Adenocarcinoma

Matthew Stenger  /  January 25, 2020

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)...

Hematologic Malignancies
Lymphoma

Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Matthew Stenger  /  August 10, 2019

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...

Solid Tumors
Bladder Cancer

Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin

Matthew Stenger  /  September 10, 2017

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...

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