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.
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.
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%.
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.
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.

Adoption of healthcare economic information communication could improve formulary decision-making and increase patient access to drugs, suggest Peter R. Fendt, PharmD, MBA, and colleagues.

In association with the approval of the first chimeric antigen receptor (CAR) T-cell therapy, on August 30, 2017, the FDA also accelerated the approval of a new indication as an orphan drug for toci­lizumab.
On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg; Pfi­zer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML. It is approved as an orphan drug for this indication.
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