FDA approves Astellas urothelial cancer treatment

The FDA approved Dec. 18 Astellas Pharma's cancer treatment, Padcev, designed to target specific cancer cells to treat urothelial cancers. 

Urothelial cancer accounts for more than 90 percent of bladder cancers, and bladder cancer is the sixth most common form of cancer in the U.S.

Padcev is made to treat adult urothelial cancer patients with tumors that are either too large to be surgically removed or that have cancer cells that have spread to other parts of the body. It is for patients who have already been treated with chemotherapy and immunotherapy. 

Padcev is expected to cost $110,000 to $120,000 depending on a patient's weight and length of treatment, according to Pharmaphorum

In a clinical trial, Padcev caused tumor shrinkage in 44 percent of patients. The most common side effects included fatigue, nerve damage, decreased appetite and hair loss.

It also may cause high blood sugar, and patients' blood sugar levels should be closely monitored during treatment. They should also be monitored for new or worsening nerve damage and have doses adjusted if needed. 

The treatment also can damage a developing fetus or newborn or complicate childbirth. 

The FDA granted Padcev accelerated approval.

Read the full news release here

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