Dovitinib Submitted to FDA for Approval to Treat Renal Cell Carcinoma

According to a recent article, the drug dovitinib has been submitted to the FDA for pre-marketing approval as a third-line therapy for patients diagnosed with renal cell carcinoma (RCC).

Renal Cell Carcinoma (RCC)

Renal cell carcinoma is a type of kidney cancer that spreads easily to the lungs and other organs. There have also been several reports of this “metastatic” renal cell carcinoma in rare sites in the body. However, usually, it begins as just one tumor in a kidney, though it can be found in both kidneys at once. Although rare, renal cell carcinoma is the most common kind of kidney cancer in adults. Renal cell carcinoma is more common in males than females and especially common between the ages of 50 and 70.

Symptoms:

Some patients with renal cell carcinoma are asymptomatic, especially early on, and some patients do not have symptoms until the cancer has spread to another part of the body. When symptoms occur, they include:

  • Blood in the urine (most common) or rusty-colored urine
  • Abdominal pain
  • Weight loss
  • Enlarged testicle or varicose testis vein
  • Fever
  • Vision abnormalities
  • High blood pressure
  • Fatigue

Dovitinib

Dovitinib is a pan-tyrosine kinase inhibitor that targets various growth factors and receptor tyrosine kinases (RTKs).  The receptors it targets are ones that promote rapid reproduction of tumor cells and aid with the survival of some cancer cells. Small molecule pan-tyrosine kinase inhibitors have already been used to treat several types of tumors and have proven to be successful.

The Trial

570 patients participated in a phase 3 trial. The trial compared the use of dovitinib versus sorafenib (Nexavar) as a third-line treatment for metastatic RCC. The 570 patients were randomized, with 284 of the patients receiving the experimental drug and 286 patients being the control arm.

After a little over 11 months, researchers found the median progression-free survival was 3.7 months compared to the 3.6 months of those in the control arm.

There were some adverse events that occurred with dovitinib including hypertriglyceridemia, fatigue, hypertension, and diarrhea.

Looking toward the future, this possible new therapy is very exciting for oncologists and their patients.

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