Thursday, 02 July 2009
OSLO, NORWAY (Press Release) - June 30, 2009 - Photocure announces today that a New Drug Application (NDA) has been submitted to the US Health Authorities (FDA) to obtain approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy.
The NDA includes clinical data from 1838 patients, comprising two recently completed clinical studies, one Phase III pivotal study in 789 patients from EU/US and a Phase III study performed in Denmark in 233 patients. The NDA includes analyses in patients with papillary bladder cancer from earlier Phase III studies. The pivotal Phase III study shows a significantly improved detection (p=0.001) of non-invasive papillary bladder cancer in fluorescence cystoscopy with Hexvix compared to standard cystoscopy followed by a significant reduction in recurrence at 9 months (p= 0.026). The results from the pivotal Phase III study are supported by the Danish Phase III study which showed similar reduction in recurrence. All studies in the documentation demonstrate that fluorescence cystoscopy using Hexvix significantly improves detection of papillary bladder cancer compared to standard white light cystoscopy.
Photocure, in collaboration with GE Healthcare, has had several meetings with the FDA, leading up to this submission and the results of the pivotal Phase III study have been presented to the FDA.
All Hexvix clinical studies have been conducted using endoscopy equipment from Karl Storz, which enables cystoscopy using both standard white light and the blue light necessary for fluorescence cystoscopy.
The Principal Investigator of the pivotal Phase III study, Professor H. Barton Grossman at MD Anderson Cancer Center comments:" There is a significant need to improve the detection of bladder cancer in the US population and to reduce the recurrence of this disease. Based on the recently published clinical data from this study Hexvix will be an important tool in improving detection and treatment of bladder cancer in the US market."
Kjetil Hestdal, President and CEO of Photocure comments: "The NDA submission is a very important step for Photocure. With these excellent clinical data included in the NDA, Photocure is looking forward to receiving FDAs view on the NDA."
About Photocure
Photocure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer.
Photocure has two proprietary pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products and technologies. For more information about Photocure, visit our website at www.photocure.com
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.
Bladder cancer is the fourth most commonly diagnosed malignancy in men and tenth among women. The recurrence rate for patients with non-invasive bladder cancer is 50-70%. Bladder cancer is one of the most expensive cancers to treat because of its combination of long survival and intensive and costly routine monitoring and treatment due to the recurrent nature of the disease.
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Photocure application to FDA
- By Kyle-MO
- Posted July 3, 2009 at 4:41 pm · 13 replies
- In Living with non-invasive bladder cancer
- Shared with the public
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- By Moonerj
- Posted July 3, 2009 at 4:48 pm
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Thanks for posting Kyle. MDA TEXAS, the top bladder cancer hospital in the USA recommends. I have finally have some Texans who agree with me regarding the importance of this new technogly. Although I am sure Lynda and Bob always agreed.
The Principal Investigator of the pivotal Phase III study, Professor H. Barton Grossman at MD Anderson Cancer Center comments:" There is a significant need to improve the detection of bladder cancer in the US population and to reduce the recurrence of this disease. Based on the recently published clinical data from this study Hexvix will be an important tool in improving detection and treatment of bladder cancer in the US market."
- By Kyle-MO
- Posted July 3, 2009 at 4:58 pm
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Jack,
If approved, I hope they don't drag their feet on insisting it be used in all Urologists offices. I really think it is a fine tool for diagnosis and treatment.
I am sure the OTHER Texan would have to agree with us now :-)
- By Cheyenne
- Posted July 3, 2009 at 5:52 pm
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You guys are out to get me. My point about this in jack's discussion is that it is a longs ways from being used. It can be approved and put into use, but I still think it is five years down the road before we know that it is effective in its application by urologists. I'm not saying it doesn;t work, I think it is going to be confronted with health care payment issues, false negative and positives, resistant to use by urologists etc.
Thanks Kyle for the info, well done. I guess I am a skeptic.
- By Cheyenne
- Posted July 3, 2009 at 5:59 pm
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We need to hear from Lynda and Bob on this. Come on you guys. HELP
- By Julie7
- Posted July 4, 2009 at 12:44 pm
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This method has been used several years in Europe and has been very effective in seeing CIS.
- By Cheyenne
- Posted July 4, 2009 at 8:10 pm
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Thanks Julie. Are most urologists using it, or it mandatory in Europe?
- By Julie7
- Posted July 5, 2009 at 12:40 pm
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I believe it is widely used in Europe. I don't think it is mandatory just highly recommended. People on the ACOR Bladder Cafe list have been eagerly waiting for this technology to be used in the US.
- By Cheyenne
- Posted July 5, 2009 at 2:04 pm
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Blue light is not a treatment for bladder cancer but is a new method of detecting early (superficial) bladder cancer. It is also called fluorescence cystoscopy.
It works by making it easier for the doctor to see areas of cancer in the bladder. This may be useful in helping doctors to:
* remove more of the cancer in the bladder
* detect a type of bladder cancer called bladder cancer-in-situ (CIS)
* choose the most appropriate treatment for each person.
Doctors diagnose bladder cancer and monitor the bladder after treatment using a small, flexible, fibre-optic telescope called a cystoscope. During cystoscopy a white light is used to show up areas of the bladder that may be abnormal. But this type of light doesn't always show up all of the cancer in the bladder.
Blue light cystoscopy can show up cancers in the bladder that might be missed by standard white light cystoscopy. Firstly, a chemical, which glows brightly when blue light is shone on it, is put into the bladder. The chemical, called hexaminolevulinate (HAL or ALA), is left in the bladder for at least an hour while it is absorbed by any cancer cells. After this the doctor uses a cystoscope fitted with a blue light to show up areas of cancer in the bladder.
Cancers in the lining of the bladder often grow back after they are removed. Doctors may use additional treatments to reduce the risk of this happening. How the bladder looks at cystoscopy helps the doctor to decide if extra treatment may be needed as well as which treatment to give. Some doctors think that blue light cystoscopy may help them to choose the best treatment for each patient.
Because blue light cystoscopy is so new there are still a number of questions about how best to use it and we don't yet know for sure whether it helps to improve the treatment for early bladder cancer. There are also some concerns that it may mean some people are given treatment that they don't need.
Sometimes doctors see changes in parts of the bladder of people with bladder cancer that look like cancer. But, once they are removed they turn out to be non cancerous. When this happens it is called a false positive. Doctors want to avoid false positives because they mean people having treatment, such as operations to remove the ‘cancers’ that they don't need. Some doctors are concerned that the number of false positives seems to be a bit higher with blue light cystoscopy than with white light cystoscopy.
Further research trials are planned to find out how best to use blue light cystoscopy. In the meantime there are very few centres in the UK where it is available. Your specialist will be able to talk over with you if it is appropriate for you and whether you could be referred to one of these centres.
References
* Jocham D et al 2005. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: A prospective, phase III multicenter study. The Journal of Urology 174(3) 862-866.
* Steinberg G 2005 Editorial comment. The Journal of Urology 174(3) 866.
- By Moonerj
- Posted July 5, 2009 at 6:21 pm
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Cheyenne
What year was this article written?
Batter Up
Jack
- By Moonerj
- Posted July 5, 2009 at 6:39 pm
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This is 2009 correct. So maybe there are many centers in UK with the light. The trials are now complete.
- By Cheyenne
- Posted July 5, 2009 at 6:43 pm
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Is it 2009? Good thing I signed with the Cowboys.
But my thinking is that in the U.S. this will meet formidable opposition. OK, I'm out of here, in enough trouble.
- By Kyle-MO
- Posted July 6, 2009 at 1:01 pm
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I don't think there will be much opposition from the FDA, but I could imagine the insurance companies will chime in about cost differance.
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