Canadian Health Authorities approve updated and expanded label for Cysview
Oslo, Norway, March 22, 2024: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces the reception of the Note of Compliance from Health Canada this week, approving the updated Product Monograph for Cysview® in Canada.
The updated indication now covers non-muscle invasive bladder cancer in general, including detection of carcinoma in situ (CIS), a very aggressive form of bladder tumor that is difficult to detect because of its flat shape.
The indication now reads:
“CYSVIEW (hexaminolevulinate hydrochloride) is indicated for:
As an adjunct to white-light cystoscopy in the diagnosis and follow up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection.”
In addition, there has been a confirmation of the safe use of Cysview, by update of the safety sections of the Product Monograph, and a clarification that no safety risk has been identified by repeated use of Cysview.
“At Photocure we continue to work on strengthening the evidence in support of Hexvix/Cysview to expand patient access to BLC and its benefits. The expanded label indication of Cysview in Canada is an important step to broadening use in this country given the favorable safety confirmation and inclusion of CIS in the prescribing information”, said Anders Neijber, Chief Medical Officer of Photocure. “The future of NMIBC detection, diagnosis, and management lies in the integration of a combination of novel detection technologies, precision diagnostics, and individualized treatment strategies. Available techniques such as blue light cystoscopy with Cysview have already contributed to improvements in the diagnostic staging of NMIBC and we’re glad that its benefits continue to be recognized all over the world.”
About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [February 2024].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to https://photocure.com/partners/our-partners for further information on our commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com