Love Maharashtra? Then you wil love Marathikatta!
Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                    Movies   Aviation   Pharma   About Us   Feedback   Links
NEXAVAR KIDNEY CANCER DRUG
 


Nexavar - Kidney cancer drug gets Swiss nod

Nexavar is used for the treatment of patients with advanced kidney cancer.

BY OUR PHARMA CORRESPONDENT
April 4, 2006

Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar (sorafenib) tablets for the treatment of patients with advanced kidney cancer, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. said in a press statement.

The drug is indicated in renal cell carcinoma (RCC),after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN).

Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland.

This is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of 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-B, KIT, and FLT-3.

Nexavar has been studied in more than 20 tumor types and in nearly 8,000 clinical trial patients. It is currently in phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A phase III clinical trial in non-small cell lung cancer (NSCLC) was initiated in February 2006. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.

However, the drug makers alert that based on the current, approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

Nexavar is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50 percent of the development and marketing costs for Nexavar worldwide, except in Japan. In return, Onyx has a 50/50 profit share in the United States, where the companies co-promote the product. In all other countries (except Japan) Bayer has exclusive marketing rights and Onyx's profit share is slightly less than 50 percent. In Japan, Bayer will fund product development and Onyx will receive a royalty.

Nexavar was approved by the U.S. Food and Drug Administration (FDA) in December 2005. In September 2005, Bayer filed for regulatory approval with the European Medicines Agency (EMEA). Pending a favorable review, market availability is possible in the EU countries in the second half of 2006. In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada, and Turkey.

More related stories from Pharma


Healing prayers no cure for the ill, says study

Pulmonary hypertension drug PulmoLAR in human trial

Pharma markets in China, Korea, Mexico, Russia & Turkey gather pace

Pfizerís anxiety drug Lyrica gets EU nod

Asymmetrical breasts: A presage to cancer?

Dream to eradicate polio still far off

GlaxoSmithKline loses fluticasone case

Able files recast plan with bankruptcy court

Ranbaxy in pact with Zenotech on cancer drugs

Lupin and Aspen to form JV on TB drugs

Blood cancer drug Ceflatonin gets orphan drug status

Bangladesh to set up API park; to export drugs worth Tk 8.50 cr to Burma

Wockhard Limited: A profile
Cipla Ltd company profile

 

 

 

Auto news for auto freaks! iDrive.in
DWS community! / Cricket blog

 

Latest Stories in Pharma

 Vertex commences phase II studies for Aurora kinase inhibitor VX-680

GlaxoSmithKline starts H5N1 avian flu vaccine trials in Germany, Belgium

Novartis acquires rights for two drug leads

Serono plans major acquisitions

Samaritan to sell Amphocil in Greece

HIV infection cases fall in South India

Flu drug: Erimos, NC State University seek patent for EM-1421

HollisterStier inks pact with Prism Pharma on cardiovascular drug PM101

Erbitux approved for head and neck cancer in Europe

EPIX Pharmaceuticals merges with Predix

Avanir's involuntary emotional expression disorder (IEED) drug Neurodex gets priority review

 Death of women raises alarm on abortion pillís safety

Prestwick gets approvable letter for Xenazine for treatment of chorea with HD

Nexavar - Kidney cancer drug gets Swiss nod

Anti-rejection drug Prograf approved in US

 

Latest Stories in Pharma

Archived Pharma stories

 

Latest updates    Contact Us - Feedback    About Us