In the News

Keytruda Receives 2 New Indications: Metastatic Cervical Cancer and Relapsed Mediastinal Large B-Cell Lymphoma

August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO 2018 Highlights - FDA Approvals, News & Updates

On June 12, 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent or metastatic cervical cancer that progressed during or after chemotherapy and whose tumors express PD-L1, as determined by an FDA-approved test. Concurrently, the [ Read More ]

Venclexta Indicated for CLL or SLL, Alone or in Combination with Rituxan

August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO 2018 Highlights - FDA Approvals, News & Updates

On June 8, 2018, the FDA approved venetoclax (Venclexta; AbbVie/Genentech) for patients with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma (SLL), regardless of 17p deletion, who received previous therapy, as monotherapy or in combination with rituximab (Rituxan; Genentech). [ Read More ]

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

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Ovarian Cancer

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. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them. [ Read More ]

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

Loretta Fala

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lymphoma

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. In the United States, approximately 72,000 new cases of NHL are diagnosed annually; more than 20,000 people were estimated to die from the disease in 2017. [ Read More ]

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

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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 the disease. Approximately 60% to 70% of adults with AML respond to initial treatment with cytotoxic chemotherapy. However, the 5-year survival rate for patients with AML remains poor at approximately 27%. [ Read More ]

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

Loretta Fala

2018 Third Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

Breast cancer affects more women than any other type of cancer, and represents 15% of all new cancer cases in the United States. A total of 252,710 new breast cancer cases were estimated to be diagnosed in 2017, and more than 40,600 deaths. The prognosis worsens for patients with locally advanced breast cancer and even more so for those with metastatic disease. [ Read More ]