Here’s what you should know.
1. FDA’s Acting Director of the Office of Hematology and Oncology Products Richard Pazdur, MD, said this is the first FDA-approved treatment option patients can use if they stop responding to Sorafenib.
2. Researchers studied Stivarga’s safety and efficacy in a randomized trial of 573 patients with HCC whose tumors remained active after Sorafenib treatments.
3. The trial measured length of time the patient lived after treatment, length of time the tumor grew after treatment and the percent of patients whose tumors survived the treatment.
4. The results were as follows:
- Median overall survival was 10.6 months for Stivarga patients and 7.8 months for patients on a placebo
- Median progression-free survival rate for patients on Stivarga was 3.1 months compared to 1.5 months for patients on a placebo
- Overall response rate for Stivarga patients was 11 percent, compared to 4 percent for patients on a placebo
5. The FDA granted Stivarga priority review and orphan drug designation.
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