2018 Third Annual Oncology Guide to New FDA Approvals


FDA Approvals, News & Updates

Welcome to the Third Annual Oncology Guide to New FDA Approvals

The Lynx Group is pleased to bring you the Third Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and [ Read More ]

FDA Approvals, News & Updates

FDA Approvals in 2017 Represent a 21-Year High

Gary M. Owens, MD 

In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high. In addition to these impressive approvals, the first-ever 3 gene therapies were also approved. [ Read More ]

FDA Approvals, News & Updates

FDA Approvals of Brand-Name Prescription Cancer Drugs in 2017

The cancer drugs included in this review were approved for the first time or received additional approvals by the US Food and Drug Administration in 2017 and are grouped here [ Read More ]

FDA Approvals, News & Updates, Lung Cancer

Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

Lisa A. Raedler, PhD, RPh 

Lung cancer is one of the most common cancers in men and women, and is the leading cause of cancer-related mortality in the United States.1 According to the American Cancer [ Read More ]

FDA Approvals, News & Updates, Leukemia and Lymphoma

Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in Adults

Lisa A. Raedler, PhD, RPh 

Mantle-cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma (NHL), comprising approximately ≥4% of NHL cases in the United States.1 Mantle-cell lymphoma most often affects men aged ≥60 [ Read More ]

FDA Approvals, News & Updates, Leukemia and Lymphoma

Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease

Lisa A. Raedler, PhD, RPh 

Marginal-zone lymphoma (MZL) 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.1 [ Read More ]

Bladder Cancer, FDA Approvals, News & Updates

Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer

Lisa A. Raedler, PhD, RPh 

Urothelial carcinoma is the primary subtype of bladder cancer, which is the sixth most common cancer in the United States.1,2 More than 79,000 cases of bladder cancer were estimated to [ Read More ]

Breast Cancer, FDA Approvals, News & Updates

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

Lisa A. Raedler, PhD, RPh 

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 [ Read More ]

FDA Approvals, News & Updates, Leukemia and Lymphoma

Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy

Contributions By Loretta Fala 

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that affects the white blood cells (lymphocytes).1 In 2017, 5970 new patients were estimated to be diagnosed [ Read More ]

FDA Approvals, News & Updates, Multiple Myeloma

Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma

Lisa A. Raedler, PhD, RPh 

Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure.1,2 According to the American Cancer Society, more than [ Read More ]

Bladder Cancer, FDA Approvals, News & Updates

Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Lisa A. Raedler, PhD, RPh 

Urothelial carcinoma is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States.1 In 2017, more than 79,000 bladder cancer [ Read More ]

Breast Cancer, FDA Approvals, News & Updates

Verzenio (Abemaciclib) a New CDK4/CDK6 Inhibitor Approved for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Contributions By Loretta Fala 

Breast cancer affects more women than any other type of cancer, and represents 15% of all new cancer cases in the United States.1 A total of 252,710 new breast cancer [ Read More ]

FDA Approvals, News & Updates, Leukemia and Lymphoma

Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia

Lisa A. Raedler, PhD, RPh 

Acute myeloid leukemia (AML) is a rare but deadly cancer. Approximately 21,400 new cases of AML were diagnosed in 2017 in the United States, and nearly 10,600 people died from [ Read More ]

FDA Approvals, News & Updates, Leukemia and Lymphoma

Yescarta (Axicabtagene Ciloleucel) Second CAR T-Cell Therapy Approved for Patients with Certain Types of Large B-Cell Lymphoma

Contributions By Loretta Fala 

Diffuse large B-cell lymphoma (DLBCL), a form of cancer that starts in the lymphatic system, is the most common type of non-Hodgkin lymphoma (NHL) in adults.1,2 In the United States, [ Read More ]

FDA Approvals, News & Updates, Ovarian Cancer

Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lisa A. Raedler, PhD, RPh 

In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum.1 According to the [ Read More ]