Corporate News Blog - Exelixis Submits US Supplemental New Drug Application for CABOMETYX(R) for the Treatment of Previously Untreated Advanced Kidney Cancer
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LONDON, UK / ACCESSWIRE / August 18, 2017 /Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Exelixis, Inc. (NASDAQ: EXEL) following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=EXEL. The Company announced on August 16, 2017, the submission of a supplemental New Drug Application (sNDA) to US Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on results from the CABOSUN randomized phase-2 trial of CABOMETYX in patients with previously untreated advanced RCC with intermediate or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). sNDA is an application to the FDA that, if approved, will allow the Company to make changes to a previously approved product label, patient population, and formulation. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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On April 25, 2016, FDA approved CABOMETYX for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, based on results from the phase-3 METEOR trial.
CABOMETYX, if Approved, will Demonstrate Statistically Significant Progression-Free Survival Benefit over Sunitinib
Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis, stated that the Company is focused on improving care and outcomes for patients with cancer. After the successful launch of CABOMETYX for patients with previously treated advanced RCC, the submission of thissNDA for CABOMETYX as a treatment in the first-line RCC setting represents an important milestone for the Company as a whole.
Morrissey further added that CABOMETYX, if approved, will offer an important new alternative for the treatment of patients with previously untreated advanced RCC, having demonstrated a clinically meaningful and statistically significant progression-free survival benefit over sunitinib, a current standard of care. He also expressed his gratitude to study patients and clinicians who participated in the CABOSUN trial, the Alliance, and NCI-CTEP, as well as our dedicated clinical, medical and regulatory teams for bringing Exelixis one step closer to its goal of expanding the population of patients who may benefit from CABOMETYX.
IRC Confirmed Results from CABOSUN, the Phase 2 Trial of Cabozantinib versus Sunitinib
The Alliance conducted CABOSUN for Clinical Trials in Oncology as part of Exelixis' collaboration with the National Cancer Institute's Cancer Therapy Evaluation Program (NCI-CTEP). On May 23, 2016, Exelixis announced that CABOSUN demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) compared with sunitinib in patients with advanced intermediate or poor-risk RCC as determined by investigator assessment.
On June 19, 2017, Exelixis announced the analysis of the review by a blinded independent radiology review committee (IRC), confirming the primary efficacy endpoint results of investigator-assessed PFS from the CABOSUN randomized phase-2 trial of cabozantinib compared with sunitinib.
About CABOSUN Study
CABOSUN is a randomized, open-label, active-controlled, phase-II trial studies determining how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. The trial enrolled 157 patients.
About Advanced Renal Cell Carcinoma
RCC is a kidney cancer that originates in the lining of the proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. RCC is the most common type of kidney cancer in adults.
About CABOMETYX® (cabozantinib)
CABOMETYX, the tablet formulation of cabozantinib, is a prescription medicine for treating people with advanced kidney cancer, RCC, which has spread or grown after treatment with other cancer medications. In January 2016, Exelixis and Ipsen announced an exclusive licensing agreement for the commercialization and further clinical development of cabozantinib for all future indications in Japan, including RCC.
CABOMETYX may cause serious side effects, including severe bleeding; tear in stomach or intestinal wall; blood clots; stroke; heart attack; chest pain; hypertension; diarrhea;and Reversible Posterior Leukoencephalopathy Syndrome (RPLS).
Last Close Stock Review
At the closing bell, on Thursday, August 17, 2017, Exelixis' stock rose slightly by 0.37%, ending the trading session at $26.88. A total volume of 3.07 million shares have exchanged hands. The Company's stock price skyrocketed 27.82% in the last three months, 18.68% in the past six months, and 153.11% in the previous twelve months. Moreover, the stock soared 80.28% since the start of the year. The stock is trading at a PE ratio of 142.22 and currently has a market cap of $7.88 billion.
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