Exelixis, Inc. (NASDAQ:EXEL) has submitted its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX (cabozantinib) tablets. The new treatment is primarily for attending to patients who have previously been treated for advanced hepatocellular carcinoma (HCC). The company says that the suitability of the drug is in its usability for 2.2 months longer than patients who received placebos in a phase 3 trial.
The president and Chief Medical Officer, Exelixis Gisela Schwab, cites that they are optimistic about the results from the regulatory authorities once the reviewing process is complete. The company’s objective is to meet the needs of an underserved patient community by bringing CABOMETYX nearer to the people diagnosed with advanced hepatocellular carcinoma.
The urgency of bringing new treatment options to the patient population
The New Drug Application by Exelixis comes at a time when the market is in high demand for treatment options. It is sad how hundreds of diseases are resisting the already existing treatment. However, Schwab explains the confidence they have in bringing new treatment options to the entire population. The officer also commends the study patients and clinicians who participated in the CELESTIAL trial. From the new development, it is quite clear that Exelixis is about to obtain its goal of exploring the potential of CABOMETYX.
CABOMETYX tablets are not only approved in the United States but also in the European Union, Norway, Iceland, South Korea, Switzerland and Australia. On the other hand, Exelixis approved exclusive rights to Takeda Pharmaceutical Co Ltd (ADR)
(OTCMKTS:TKPYY) Company Limited whereby it will be charged with the commercialization and further clinical development of cabozantinib. The FDA has also previously offered an orphan drug designation to cabozantinib for the treatment of advanced HCC.
Let us explore HCC
Liver cancer is now the second largest cause of cancer-related deaths in the world. Records have it that it is responsible for 700,000 to 800,000 deaths each year. On the other hand, HCC is regarded as the most common form of liver cancer taking up to about three-fourths of the nearly 42,000 cases in the US. HCC has survival window of 6 months if the patient does not receive treatment.