New medicine to treat non-muscle invasive bladder cancer
Anktiva provides an alternative to surgery for patients whose cancer does not respond to treatment with Bacillus Calmette-Guérin
NewsHumanMedicines
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading (carcinoma in situ, with or without papillary tumours). Anktiva is used when the cancer does not respond to treatment with Bacillus Calmette-Guérin (BCG), a therapy that stimulates the immune system to help treat bladder cancer.
Anktiva is given as a solution directly into the bladder, together with BCG, once a week for 6 weeks, and then as maintenance therapy.
Bladder cancer is one of the most common cancers in the EU, affecting over 200,000 people each year, with most cases being NMIBC. Current recommendations for treating patients with high-risk NMIBC consist of surgical removal of the cancer, followed by treatment with BCG. However, in many patients the cancer does not respond or comes back despite treatment with BCG. There are currently no authorised treatments for NMIBC when it does not respond to BCG. The main treatment option is surgery to remove the bladder. While this can cure NMIBC, it carries risks, affects the quality of life of patients and is not an option for everyone. Anktiva offers a new treatment option for patients and addresses an important unmet need.
Anktiva is a type of immunotherapy that binds to a protein in the immune system known as the interleukin-15 (IL-15) receptor. This activates cells in the immune system that target and destroy cancer cells.
EMA’s recommendation is based on the results of a single-arm clinical trial in 100 adults with BCG-unresponsive NMIBC who received Anktiva in combination with BCG given into the bladder weekly over 6 weeks. In 71% of patients, signs of cancer disappeared and this response lasted for about 27 months on average.
The most common side effects reported with Anktiva were dysuria (painful urination), haematuria (blood in the urine), pollakiuria (abnormally frequent urination), urinary tract infection, micturition urgency (sudden, strong need to urinate), tiredness, chills, musculoskeletal pain and fever.
Anktiva is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.
In order to confirm the efficacy and safety of Anktiva, the company has committed to submit long-term follow-up results of ongoing studies.
The opinion adopted by the CHMP is an intermediary step on Anktiva’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.
Notes:
- The assessment report with relevant references will be published once the European Commission has issued a decision.
- The applicant for Anktiva is Serum Life Science Europe GmbH.