Two game changing news has come together on October 16, 2017, both indicating that Exelixis (EXEL) is on its way to reach its goal becoming the leader in the current oncology discovery and development field.
THE FIRST GOOD NEWS announced that the U.S. Food and Drug Administration (FDA) determined that Exelixis’ supplemental New Drug Application (sNDA) for the approval of Cabometyx® in patients with previously untreated advanced renal cell carcinoma (RCC) is sufficiently complete to permit a substantive review. In the same time, the FDA granted priority review for the product, assigning a Prescription Drug User Fee Act (PDUFA) action date February 15, 2018.
The supplemental new drug application (sNDA) is based on data from the CABOSUN trial, which is a randomized phase 2 trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).
THE SECOND GOOD NEWS announced that the global Phase 3 CELESTIAL trial in patients with advanced hepatocellular carcinoma (HCC) met its primary endpoint of overall survival (OS) with statistically significant results. The data demonstrate meaningful clinical improvement compared to placebo. The safety data from the study were consistent with the established profile of cabozantinib.
Based on these good results, the independent data monitoring committee for the study recommended that the trial should be stopped for efficacy. Also, the positive results led Exelixis to decide upon submitting a supplemental New Drug Application (sNDA) to the FDA in the first quarter of 2018. In the meantime, Exelixis will discuss the trial results with regulatory authorities and determine the next steps for the trial, including offering patients currently receiving placebo the opportunity to cross over to cabozantinib.
In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. An orphan drug designation is granted for the treatments of diseases that affect fewer than 200,000 people. It also provides incentives, which include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits, and waiver of certain FDA fees.
October 16, 2017 is an important day in Exelixis’ life. The couple of announced good news at that day mark an important milestone in the firm’s efforts to validate its small molecule targeted products as essential in the treatment of various cancers. Advanced Kidney cancer and liver cancer are deadly diseases and need more treatment options than the currently available products.
Regarding renal cell carcinoma (RCC), according to The American Cancer Society’s 2017 statistics, kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Clear cell renal carcinoma is the most common type of kidney cancer in adults. In case the cancer is detected in early stages, the survival rate for RCC increases; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease. Around 30,000 patients in the U.S. and 68,000 globally require treatment, and an estimated 14,000 patients in the U.S. each year are in need of a first-line treatment for advanced kidney cancer.
The majority of clear cell renal carcinoma tumors have lower levels of the von Hippel-Lindau protein, which causes higher levels of MET, AXL and VEGF. These proteins promote tumor angiogenesis, growth, invasiveness and metastasis. MET and AXL may also provide escape pathways that drive resistance to VEGF receptor inhibitors. Cabozantinib sold as Cabometyx for kidney cancer is the only product that targets the same cancer promoting proteins in the clear cell renal carcinoma, i.e., the MET, AXL and VEGFR-1, -2 and -3
Liver cancer is one of the three leading causes of death around the world. The most common form of liver cancer is hepatocellular carcinoma (HCC), which makes around 75% of the diagnosed cases. Nearly 800,000 new cases are diagnosed annually, and the disease accounts for more than 700,000 deaths each year.
Exelixis history is important to know. How this firm has created its in house capability in discovering its targeted small molecule products and how it managed to develop the most promising products on its own, without the need for outsiders’ help, hence, not forfeiting shareholders’ interests by giving the bulk of the drugs’ sales revenues to others.
In the meantime, Exelixis brought in collaborators following the approval of its products. It signed deals with large firms that have marketing experience, enabling them to market and sell its approved products in limited overseas and other foreign countries only. Exelixis is one of the rare firms that discovered, developed and marketed its own products in the United States and, as you have seen yesterday, it is accomplishing its tasks with utmost success.
Less than a couple of weeks ago, EXEL lost over 20% of its value as a result of exaggerating the fact that a member of the firm’s management sold some stock. On October 16, 2017, EXEL recuperated its temporary unwarranted losses and rallied to a historical high, fascinating its loyal holders who double celebrated Exelixis’ remarkable day.
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