Product | 06.03.2024
From April 2023 onwards, medac GmbH will be able to reliably supply all markets with an existing BCG-medac marketing authorisation and active marketing status with the immunotherapy product for the treatment of non-muscle invasive bladder cancer (NMIBC). This step has been made possible through the stable expansion of production capacities, which also enables the company to meet a future rise in demand for BCG-medac.
During the 38th annual congress of the European Association of Urology (EAU) in Milan, medac GmbH announced that from April 2023 onwards, each prescription of BCG-medac for the treatment of NMIBC in markets with an existing BCG-medac marketing authorisation and active marketing status will be fulfilled. Based on the demand and indication growth (according to the WHO), this means that each patient can be treated with BCG in line with the EAU guideline 1. Jørgen Bjerggaard Jensen, clinical professor and chair of urology at Aarhus University, Denmark, and member of the European Association of Urology guideline panels emphasised the relevance of BCG as gold standard in the treatment of high-risk NMIBC: “To be safe in the knowledge that NIMBC can now once again be treated reliably with BCG is of huge significance in clinical practice – in particular for high-risk patients.”
The small number of manufacturers, together with a rising global demand for BCG made it difficult in the past to guarantee a reliable supply of the immunotherapy product.
BCG-medac is available in a closed instillation system which allows healthcare professionals to reconstitute the immunotherapy product directly at the patient’s hospital bed immediately before use. The fixed adapter connection with a metal spike between the transparent vial containing freeze-dried BCG-medac and the handy PVC bag with the solvent as well as the seal in the catheter connector of the instillation system minimise the risk of leakage and contamination – and thereby increase safety for both users and patients.
BCG-medac is authorised for the treatment of non-muscle invasive bladder cancer (NMIBC).2 This includes the curative treatment of carcinoma in situ as well as the prophylactic treatment of recurrence of urothelial carcinoma limited to mucosa, Ta G1-G2 if multifocal and/or recurrent tumour, Ta G3, urothelial carcinoma in lamina propria but not the muscular layer of the bladder (T1), and carcinoma in situ.
As a global pharmaceutical company based in Germany, medac GmbH has been specialising for more than fifty years in the diagnosis and treatment of oncological, urological and autoimmune diseases. The company can look back on a long tradition of high-quality instillation therapies for bladder cancer: For instance, to increase the personal safety of users, medac GmbH developed the first closed instillation system which today is equipped as standard with the bladder cancer drugs Mitomycin medac or BCG-medac. Thereby, medac GmbH has a dual first-line treatment concept for the adjuvant treatment of non-muscle invasive bladder cancer (NMIBC). The objective of medac GmbH is to improve the quality of life of patients by providing high-quality therapies. Consequently, the company is working hard to guarantee the reliable supply of BCG-medac in the long term.
Find out more at www.bladdercare.com.
1 EAU Guidelines Edn. presented at the EAU Annual Congress Amsterdam 2022. ISBN 978-94-92671-16-5.
2 BCG-medac Summary of Product Characteristics, May 2022
“To be safe in the knowledge that NIMBC can now once again be treated reliably with BCG is of huge significance in clinical practice – in particular for high-risk patients.”
Jørgen Bjerggaard Jensen, clinical professor and chair of urology at Aarhus University, Denmark, and member of the European Association of Urology guideline panels
