Anktiva for bladder cancer: How long until it's approved in your country?

Bladder cancer is the 10th most common cancer worldwide. The majority of cases are non-muscle invasive bladder cancers (NMIBC). Bacillus Calmette-Guérin (BCG) is the standard therapy for high-risk NMIBC. However, nearly 40% of patients see treatment failure, highlighting the need for new treatment options.

With the FDA's recent approval of Anktiva (nogapendekin alfa inbakicept-pmln), a first-in-class treatment option becomes available for NMIBC patients.

While this is great news, what does it mean for patients outside the USA? Here's everything you need to know about Anktiva's EMA approval and MHRA approval. Including all your options for getting the treatment in other countries.

What is Anktiva used for?

Anktiva (also known as N-803) is indicated for use together with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) ².

How does Anktiva (N-803) work for bladder cancer?

Anktiva works by using Interleukin-15 (IL-15) to boost the activity of natural killer (NK) cells and cytotoxic T lymphocytes in the immune system, which are essential for attacking and destroying cancer cells. According to Dr Karim Chamie (Associate Professor of Urology at UCLA), this innovative approach has the potential to achieve a strong and lasting immune response. This makes it a promising development in cancer immunotherapy, with potential applications beyond NMIBC ³.

What is the success rate of Anktiva in clinical trials?

Anktiva's FDA approval was based on the results of the QUILT-3.032 clinical trial. The key trial results reported were:

• 62% of patients treated with Anktiva had a complete response to the treatment (i.e. their tumor disappeared);
• The duration of the complete response was over 47 months at data cut-off, and is ongoing;
• The number of patients who had lasting responses at 12 and 24 months was higher than the standards set by the International Bladder Cancer Group (IBCG), showing a big improvement in NMIBC treatment;
• The overall survival rate at 24 months was 94% ^3,4.

These results are considered promising, and, according to Dr Soon-Shiong, they "mark the launch of a next-generation immunotherapy beyond checkpoint inhibitors" ⁵.

So, when will this new treatment option be available to more patients worldwide?

When will Anktiva get EMA approval?

As of July 2024, there is no active EMA marketing authorization application for Anktiva (nongapendekin alfa inbakicept-pmln). That makes it difficult to provide an approval timeline estimate.

Typically, EMA approval decisions take up to 210 days. Therefore, if an approval application for Anktiva/N-803 is submitted soon, we would be looking at a possible EMA approval around mid-2025. However, this is only a theoretical possibility, as no application has been filed yet.

When will Anktiva be available to bladder cancer patients in Europe?

Approval and availability are unfortunately not the same. Even in the best-case scenario, where Anktiva gets EMA approval around mid-2025, it still won't be available across Europe immediately.

Each EU member state launches EMA-approved medicines at their own pace. Some, like Germany, are relatively quick, with an average launch time of 100 days for oncological treatments. At the other end of the spectrum is Romania, where it takes an average of 964 days for a new cancer treatment to become available ⁶.

In other words, Anktiva/N-803 could theoretically become available in some EU countries towards the end of 2025. That's all depending on a marketing authorization application being submitted within the second half of 2024. Other countries in Europe may be facing an additional couple of years of waiting time.

When will Anktiva be approved in the UK?

As of July 2024, there is no marketing authorization application submitted to the MHRA for Anktiva (nongapendekin alfa inbakicept-pmln).

However, this is not a reason to despair. According to post-Brexit regulations, the MHRA can approve medicines locally as soon as they get the green light from another trusted regulatory body (such as the EMA or FDA). This is known as the International Reliance Procedure [7]. If the MHRA decides to take this road for approving Anktiva, then (at least theoretically) a UK approval could be a fact within 2024.

When will Anktiva be available to bladder cancer patients in the UK?

If the MHRA approves the medicine soon, on the basis of its FDA approval, Aktiva will then require a NICE assessment before becoming available on the NHS. If approved, the medicine should be available to UK patients within three months of the NICE's decision date.

Assuming a best-case scenario, where the MHRA adopts Anktiva's FDA approval by the end of 2024, and NICE makes a positive decision soon after, the treatment could be available in the UK by mid-2025. However, note that this is only a theoretical timeline and the MHRA's actions in the next months will determine whether it's realistic.

How to get Anktiva before it's available in your country

If you're based outside the USA, having to wait for Aktiva's local approval may be discouraging. Fortunately, waiting is not the only thing you can do. With your treating doctor's support, you could buy Anktiva immediately via Named Patient Import.

Buy Anktiva via Named Patient Import

In most countries, patients are legally allowed to buy and import medicines that could enhance their quality of life or address life-threatening conditions. The regulation making this possible is known as Named Patient Import.

There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

• The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
• There is no alternative on the local market;
• The medicine is for personal use;
• The patient has a prescription from their treating doctor;
• The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Named Patient Import regulation to get Anktiva before its EMA approval (or its approval in the UK or elsewhere)? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying Anktiva immediately. Get in touch with us for more information.

References:

1. Management of BCG-unresponsive NMIBC. Urology Times, 12 February 2024.
2. Reference ID: 5368461. Accessdata.fda.gov, Accessed 2 July 2024.
3. What does the US FDA approval of Anktiva® signify for bladder cancer care?. Oncology Central, 20 May 2024.
4. Immunotherapy by ANKTIVA® - Treatment for NMIBC CIS. Anktiva.com, Accessed 2 July 2024.
5. A new frontier of immunotherapy for bladder cancer. AUA Daily News, 3 May 2024.
6. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 2 July 2024.
7. Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.