Navigation Links
Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen
Date:6/26/2009

CASTRES, France, June 26 /PRNewswire/ -- Laboratoires Pierre Fabre announce today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval and is recommending to grant marketing authorisation for JAVLOR(R) as monotherapy in metastatic treatment of bladder cancer (advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen).

CHMP has issued a positive opinion based on two phase II study results and on the only phase III randomized study ever conducted in the indication of metastatic treatment of bladder cancer after failure of a prior platinum-containing regimen.

When the EMEA will grant the marketing authorization, JAVLOR(R) will become the first monotherapy approved in Europe for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen, where the expectation is important for both oncologists and patients. In Europe the burden of bladder cancer is significative with an estimated 100.000 new cases and 50.000 deaths annually; most of cases are related to the use of tobacco products.

Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA, stated: "The favourable opinion of the CHMP for JAVLOR(R) confirms the therapeutic interest of our anticancer product, strengthened by the clinical data of our file. Again, it rewards the quality of work done by our colleagues dedicated to R&D. JAVLOR(R) will introduce innovative therapy to physicians and patients in an area considered as an unmet medical need".

This approval is a significant milestone for Laboratoires Pierre Fabre as JAVLOR(R) represents one of the leading products of their pipeline and these positive results reward their important efforts in oncology research.

About JAVLOR(R) (vinflunine):

Discovered by scientists at the Pierre Fabre Research Center, vinflunine is a new bi-fluorinated MTI (Microtubule inhibitor) obtained by chemistry exploiting the reactivity of Vinca scaffold in superacidic media. Such strategy, finalized in collaboration with experts at the University of Poitiers (France), enabled the selective introduction of two fluorine atoms in a part of that structure previously inaccessible by classic chemistry, thereby leading to the first bi-fluorinated vinca alkaloid.

Besides its original structure, JAVLOR(R) exhibits unique pharmacological properties and is also devoid of any unpredictable major toxicity and does not induce cumulative toxicity.

Its every 3 weeks administration enables convenient hospital treatment on an out patient basis (a 20 minutes infusion without any IV premedication).

JAVLOR(R) 25 mg/ml solution for infusion has been approved as monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.

About Laboratoires Pierre Fabre

Pierre Fabre group, France's second biggest independent pharmaceutical laboratory, achieved a turnover of 1.75 billion euros in 2008. Approximatively 10,000 people including 1,400 in the research sector, are employed.

Its therapeutical areas are ethical products, healthcare products and dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene Furterer. In 2008, Pierre Fabre Medicament dedicated 33% of its annual turnover to R&D in five main therapeutic directions: oncology, the Central Nervous System, cardiology, internal medicine /urology and dermatology.

To learn more about Pierre Fabre, please refer to http://www.pierre-fabre.com.


'/>"/>
SOURCE Pierre Fabre SA
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
2. UCLA/RAND study shows that many children of HIV-positive parents are not in their custody
3. Blue Cross and Blue Shield of Florida Reports Eighteenth Consecutive Year of Positive Performance
4. Nutrition model stresses positive experience of eating
5. Ultrasound plus mammography finds more cancers, but increases false positives
6. Oncolytics Biotech Inc. reports positive interim results of UK phase Ia/Ib trials
7. PEAK Surgical Announces Positive Surgical Incision Wound Healing Results With the PEAK PlasmaBlade(TM)
8. Facet Solutions AFRS(TM) Implant Demonstrates Positive Clinical Results After One Year Follow Up
9. Evotec Reports Positive Top-Line Results in Phase II Study With EVT 201 in Elderly Insomniacs With Daytime Sleepiness
10. A low prevalence of H pylori in HIV-positive patients
11. Drug Company-Funded Asthma Drug Studies More Positive
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... 09, 2016 , ... Traumatic Brian Injury is often in ... one of many possible sources: sports, car accidents, falls, work accidents, combat and ... Rehab Solutions for the Complexities of Concussions is designed for physical and ...
(Date:2/9/2016)... ... 09, 2016 , ... Center for Autism and Related Disorders ... spectrum disorder (ASD). Beginning Jan. 1, 2016, Medicaid is covering autism treatment in ... key to providing effective treatment for individuals with ASD. Now, over 1,800 low-income ...
(Date:2/9/2016)... ... February 09, 2016 , ... URise Products announces today ... device, the StandUp Walker. Made entirely in the USA, the StandUp Walker is ... , StandUp Walker’s novel patent-pending design offers 2-in-1 benefits of a stand-assist ...
(Date:2/9/2016)... (PRWEB) , ... February 09, ... ... print and e-book publishing software, in partnership with Snowfall4pod Digital, creators of ... a comprehensive book publishing, content management, global distribution and print-on-demand network. , ...
(Date:2/9/2016)... ... February 09, 2016 , ... On January 12, 2016 Paul McElwee, a ... they noticed their furnace not producing any heat. Shortly after entering the home, Paul ... exchanger was leaking dangerous levels of carbon monoxide into the home, at 2,000 parts ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... 10, 2016 --> ... Therapeutics and Companion Diagnostic Market to 2019 - ... Environment" research report indicates that the core personalized ... by 2020 growing at a CAGR of 8.74%. ... and targeted therapeutics and is dominated by oncology, ...
(Date:2/10/2016)... February 10, 2016 Demonstrates ... 1 receptor selectivity   1 ... which has entered clinical development as a new ... and schizophrenia.   --> 1 ... has entered clinical development as a new treatment ...
(Date:2/9/2016)... Inc. (NASDAQ: MSON ), an international surgical ... therapeutic ultrasonic products for spine surgery, skull-based surgery, ... other surgical applications, today announced financial results for ... fiscal year 2016 ended December 31, 2015. ... Highlights for the second quarter and first half ...
Breaking Medicine Technology: