Advanced Immunological Treatment and Research Medical Center

Two Cutting-Edge Cancer Drugs Now Approved by FDA

Two new cutting-edge cancer treatments, Vitravki and Xospata, have now been approved for use by the U.S. Food and Drug Administration (FDA). Both drugs were given Priority Review status, which means the FDA reviewed them in six months instead of ten.  This status allows the FDA to quickly approve drugs that promise to make significant improvements in treating, diagnosing, or preventing serious diseases. These new cancer drugs will make new strides in treating cancer patients who would otherwise have no other options.

Vitravki

Vitravki will treat adult and pediatric cancer patients who have a cancer with a specific genetic feature, also called a biomarker. It’s only the second approved cancer drug that focuses on tumor biomarkers rather than the actual organs in which tumors originate. The drug, developed by Bayer and Loxo Oncology, will be used to treat tumors with NTRK (neurotrophic receptor tyrosine kinase) gene fusions. The tumors must not be metastatic or have a known resistance mutation, and they must not have a viable alternative treatment option. Vitravki will mostly treat tumors that cannot be surgically removed or that have gotten bigger after other treatments.

NTRK genes are relatively rare, but they occur in many kinds of cancer, including mammary analogue secretory carcinoma and infantile fibrosarcoma.

The new drug may end up costing hundreds of thousands of dollars, but it’s currently unclear how much of that cost patients will actually end up paying. Bayer says that anyone who needs the drug will get it, though, as it could potentially save lives.

Xospata

clinical trial

Xospata is an oral therapy that will treat adult patients with acute myeloid leukemia (AML) who have a mutation in the FLT3 gene. AML is a quickly-progressing cancer that changes the number of red blood cells and requires patients to get ongoing blood transfusions. The tablets will work best on cancers that have relapsed or are resistant to treatments. Along with the drug, the FDA has also approved a diagnostic that will determine whether the patients have the FLT3 gene mutation.

According to Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, the FLT3 gene mutation occurs in 25-30% of patients with AML. The mutations typically coincide with an aggressive form of the cancer with an increased risk of relapse. The new cancer drug offers hope to patients who are fighting AML and have no other treatment options.