JHOP Web Exclusives

  • Darzalex Combined with Pomalidomide and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
  • Rituximab Combination Now Approved in 3 Blood Cancers
  • First FDA-Approved Test to Help Detect Several Leukemias and Lymphomas
  • DigniCap Cooling System Receives Expanded Indication for Use in Patients with Solid Tumors
  • Blincyto Receives Expanded Indication to Include Patients with Ph+ B-Cell Precursor ALL
  • First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
  • Neratinib First Extended Adjuvant Treatment for Patients with Early-Stage, HER2-Positive Breast Cancer
Prostate cancer is the second leading cause of cancer-related mortality, and accounts for 10% of cancer-related deaths in American men. It is estimated that 1 in 9 men will have prostate cancer during their lifetime, and an estimated 161,363 new cases and 26,730 prostate cancer–related deaths are expected in the United States in 2017.
  • Alunbrig, an Oral Kinase Inhibitor, Receives FDA Approval for NSCLC with ALK Mutation
  • Rydapt First Drug in Decades Approved by the FDA for Acute Myeloid Leukemia
  • Stivarga First Drug in a Decade Approved by the FDA for Liver Cancer
  • Atezolizumab Approved as First-Line Treatment for Advanced Bladder Cancer in Some Patients
  • Tagrisso Receives Full Approval for NSCLC with EGFR T790M Mutation
  • Bavencio, a PD-L1 Inhibitor, First Nonchemotherapy Drug Approved for Merkel-Cell Carcinoma
  • Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
  • Kisqali, a New CDK4/CDK6 Inhibitor, Approved for First-Line Therapy in HR-Positive, HER2-Negative Advanced Breast Cancer
  • Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
  • Revlimid Receives New Indication for Maintenance Therapy in Multiple Myeloma After Autologous Stem-Cell Transplant
  • Opdivo a New Option for Advanced or Metastatic Bladder Cancer
  • Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
  • Rubraca Receives Accelerated Approval for Advanced Ovarian Cancer
  • Zejula a New Option for Maintenance Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
  • Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
  • Kisqali, a New CDK4/CDK6 Inhibitor, Approved as First-Line Therapy for HR-Positive, HER2-Negative Advanced Breast Cancer
  • Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
  • Revlimid Approved as Maintenance Therapy for Multiple Myeloma After Autologous Stem-Cell Transplantation
  • Opdivo Now Approved for Advanced or Metastatic Bladder Cancer
  • Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
  • Rubraca a New Treatment Option for Patients with Advanced Ovarian Cancer
Results of a phase 1/2 study that investigated 2 dosing regi­-mens of 2 immunotherapies—the PD-1 inhibitor nivolumab (Opdivo) plus the CTLA-4 inhibitor ipilimumab (Yervoy)—in patients with previously treated metastatic urothelial carcinoma showed higher response rates and longer median overall survival with the regimen of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg than with the dosing of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg.
High response rates with the combination of elotuzumab (Empliciti), lenalidomide (Revlimid), and dexamethasone in the treatment of patients with high-risk smoldering multiple myeloma suggest that early intervention may be worthwhile in this patient population, based on results from a phase 2 study, said Irene M. Ghobrial, MD, Attending Physician, Medical Oncology, Dana-Farber Cancer Institute, Boston, at the 2016 American Society of Hematology meeting.
Obinutuzumab (Gazyva)-based induction and maintenance chemotherapy extended progression-free survival (PFS) compared with standard-of-care rituximab (Ritux­an)-based chemotherapy in patients with untreated follicular lymphoma, said Robert E. Marcus, MBBS, FRCP, FRCPath, King’s College Hospital, London, who presented the results from the phase 3 GALLIUM clinical trial at the 2016 American Society of Hematology meeting.
The investigational chimeric antigen receptor (CAR) T-cell therapy KTE-C19 achieved complete responses that were durable for >1 year in more than 75% of patients with aggressive lymphomas who had no other effective treatment options, according to results from the phase 2 pivotal clinical trial ZUMA-1 that were presented by Sattva S. Neelapu, MD, Department of Lymphoma/Myeloma, M.D. Anderson Cancer Center, at the 2016 American Society of Hematology meeting.
  • Rubraca Approved for Advanced Ovarian Cancer with BRCA Mutations
  • Avastin Approved for Platinum-Sensitive Ovarian Cancer
  • Darzalex Approved for Use in Combination with Standard Regimen for Multiple Myeloma
  • Opdivo Now Approved for Head and Neck Squamous-Cell Carcinoma
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