Solid Tumors

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 ]

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 ]

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

Lisa A. Raedler, PhD, RPh

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

Urothelial carcinoma is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2017, more than 79,000 bladder cancer cases were diagnosed in the United States, and more than 16,000 people died from this disease. The prognosis is favorable for patients with localized disease, with a 5-year relative survival rate of 78% for all stages of bladder cancer, which decreases to 5% for patients with distant disease. [ 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

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

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 ]

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

Lisa A. Raedler, PhD, RPh

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

Urothelial carcinoma is the primary subtype of bladder cancer, which is the sixth most common cancer in the United States. More than 79,000 cases of bladder cancer were estimated to be diagnosed, and nearly 17,000 people to die from this disease in 2017. [ Read More ]

Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

Lisa A. Raedler, PhD, RPh

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

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. According to the American Cancer Society, more than 155,000 Americans will die from lung cancer in 2017, representing approximately 25% of all cancer deaths. Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 80% to 85% of all lung cancer cases. [ Read More ]