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Last Updated: Dec 27th, 2006 - 19:07:47 |
Nexavar (sorafenib tosylate), a new anticancer drug, distributed and marketed by Bayer Pharmaceuticals Corporation, was approved for treatment of advanced renal cell carcinoma (ARCC) - the most common type of kidney cancer, the US Food and Drug Administration (FDA) announced Dec. 20.
"The approval of Nexavar to treat advanced kidney cancer brings a much needed option for this group of cancer patients," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research (CDER).
"FDA is working hard to support the development of new and effective treatments for patients with cancer and other serious illnesses who have limited alternatives."
In the US, nearly 32,000 new cases of kidney cancer are diagnosed, with nearly 12,000 people dying from the disease each year. Kidney cancer often strikes people between 50-70 years old. Men are twice more likely to contract the disease than women. If advanced, kidney cancer cannot be surgically removed or treated.
"There are currently few options for treating renal cell carcinoma once it has spread beyond the kidneys. Surgery is often not recommended for these patients, and existing treatments are limited in their effectiveness and can be highly toxic," said Ronald Bukowski, M.D., director of Cleveland Clinic Cancer Center, Cleveland.
The FDA approved the anticancer drug based on two studies of patients with advanced kidney cancer, which showed that treatment with Nexavar slows progression of the disease. In patients who received treatment with interleukin-2 or interferon, those who took Nexavar had 167 days before the tumor progressed. This is compared to 84 days in patients receiving the drug.
The common side effects include rash, diarrhea, increases in blood pressure, and redness, pain swelling, or blisters on the palms of the hands or soles of the feet, according to a news release by the FDA.
Nexavar, co-developed by Onyx and Bayer and formerly known as Bay 43-9006, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In pre-clinical models, sorafenib targeted two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-â, KIT, FLT-3 and RET.
*A bit of history about Nexavar*
An early study of Nexavar on kidney cancer treatment was reported by Dirk Strumberg, M.D., of the West German Cancer Center at the University of Essen, in June 2003 at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The report included data from four clinical Phase I single agent studies.
One analysis of 118 patients with advanced malignancies, who used Nexavar doses of 200 mg twice a day or higher, indicated Nexavar slows the progression. 29 patients remained on Nexavar for more than six months without tumor progression or serious treatment-related adverse events. Nine of them were on the drug for more than one year. The analysis showed the drug has an anticancer effect.
In one Phase II clinical trial presented in Oct. 2003 at NDDO's Second International Symposium on Signal Transduction Modulators in Cancer Therapy in Amsterdam, 41 patients with advanced and progressive RCC received Nexavar orally at 400mg twice a day for a 12-week period.
The results showed 73 percent of participants (30 patients) did not experience tumor progression within the 12 weeks. Of these patients, 44 percent (18 patients) had tumor shrinkages of at least 25 percent. 29 percent (12 patients) had their tumors stabilized within 25 percent of pretreatment size. The remaining 27 percent (11 patients) discontinued study treatment either because of progressive disease or adverse effects.
Data indicated the drug prevents tumor growth by combining two anticancer activities: inhibition of tumor cell proliferation and tumor angiogenesis.
Nexavar was granted Fast Track status in April 2004 by the FDA. The Fast Track program is designed to expedite review of drug compounds for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need for new therapeutic approaches.
In June 2004, results of a Phase II clinical trial of Nexavar used in patients with advanced RCC or kidney cancer were presented at the annual meeting of the American Society of Clinical Oncology in New Orleans. Data showed durable responses in patients who took Nexavar in addition to tumor shrinkage and disease stabilization.
In Aug. 2004, the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) granted Nexavar orphan drug status for the treatment of renal cell carcinoma.
In Oct. 2004, a Phase II trial of 502 patients (202 of which had advanced or progressive kidney cancer, showed "based on investigator assessments, 70 percent of study participants with kidney cancer had tumor shrinkage or disease stabilization. In addition to the above 65 patients with stable disease who were randomized, 79 patients continued to receive BAY 43-9006 (Nexavar) in the open-label portion of the trial," according to Bayer.
In Oct. 2004, the FDA also granted Nexavar orphan drug status. The FDA orphan drug designation provides incentives to companies that develop drugs for diseases affecting less than 200,000 people in the US.
In March, adata monitoring committee (DMC) reviewed the safety and efficacy data from the company's pivotal Phase III trial of 800 patients with advanced kidney cancer. It found use of Nexavar prolonged the progression-free survival. Bayer and Onyx prepared a new drug application for possible accelerated approval in the US.
Data from the Phase III study were presented at the American Society of Clinical Oncology meeting, May 13-17, in Orlando.
Based on the results of recent Phase III trial, Bayer recommended in April that all patients with advanced RCC who were enrolled in the trial receive sorafenib (formerly BAY 43-9006).
By May, sorafenib has been accepted into the US Food and Drug Administration's (FDA) Pilot 1 Program for continuous marketing applications. The Pilot 1 Program was designed for therapies that have been granted Fast Track status, and have the potential of providing important therapeutic benefit over available therapy.
In May, the availability of sorafenib was extended through a treatment protocol to eligible individuals with advanced renal cell carcinoma (RCC), or kidney cancer. Sorafenib has been made available to patients through qualified investigators participating in this program at clinical sites throughout the US. The protocol is known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study.
By July, Bayer and Onyx completed filing of new drug applications with the FDA for sorafenib for individuals with advanced renal cell carcinoma (RCC), or kidney cancer.
In Sept. Bayer announced the New Drug Application (NDA) for sorafenib for patients with advanced renal cell carcinoma (RCC), or kidney cancer, had been accepted for review and granted Priority Review status by the FDA.
On Oct. 28, Bayer announced selection of Nexavar(r) (sorafenib tosylate) Tablets as the global trade name for sorafenib.
In Nov, Dr. Escudier reported (based on an interim analysis) there was an estimated 39 percent improvement in survival for patients receiving Sorafenib versus those receiving. According to Dr. Escudier, "these databuild on the previously announced finding that disease progression was significantly delayed in advanced kidney cancer patients who received Sorafenib."
Earlier this month, Bayer announced the FDA had approved Nexavar(r) (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer.
The FDA approved Nexavar based on data from the largest ever randomized, placebo-controlled, international trial of patients with advanced renal cell carcinoma, in which 130 centers participated. Treatment with Nexavar resulted in approximately a doubling of progression-free-survival.
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