Clinical News

Besponsa a New Treatment Option for Patients with Relapsed/Refractory B-Cell ALL

October 2017, Vol 7, No 10 - FDA News

On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfi­zer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval. [ Read More ]

Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer

Lisa A. Raedler, PhD, RPh

September 2017, Vol 7, No 9 - Breast Cancer, Drug Update

Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 252,710 American women will be diagnosed with breast cancer and 40,610 will die from the disease in 2017. For the majority (62%) of women with breast cancer, the disease is confined to the breast, and the 5-year survival approaches 100%. However, for women with metastatic disease, the likelihood of survival at 5 years drops to 27%. [ Read More ]

FDA News – September 2017

September 2017, Vol 7, No 9 - FDA News

  • Enasidenib, a New Targeted Therapy Approved for Relapsed or Refractory AML
  • Ibrutinib First Treatment Approved by the FDA for Chronic Graft-versus-Host Disease
  • Vyxeos First Treatment Approved Specifically for 2 Types of High-Risk AML
  • First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell Acute Lymphoblastic Leukemia in Young Patients
[ Read More ]

Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma

Lisa A. Raedler, PhD, RPh

August 2017, Vol 7, No 8 - Drug Update

Marginal-zone lymphoma (MZL) is a malignancy that arises from B-lymphocytes in the marginal zone of lymphoid tissue. This slow-growing indolent B-cell lymphoma represents approximately 12% of all cases of non-Hodgkin lymphoma (NHL) in adults. MZL is divided into 3 subtypes, including mucosa-associated lymphoid tissue (MALT), nodal MZL, and splenic MZL. [ Read More ]

FDA News – August 2017

August 2017, Vol 7, No 8 - FDA News

  • 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
[ Read More ]

Select Clinical Trials Currently Enrolling Patients with Leukemia

July 2017, Vol 7, No 7 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with leukemia for inclusion in investigations of new therapies or new regimens of existing treatments for patients with leukemia. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial. [ Read More ]

FDA News – June 2017

June 2017, Vol 7, No 6 - FDA News

  • 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
[ Read More ]