Inavolisib for breast cancer: When is approval coming (from the FDA, EMA, and more)?

In May 2024, the combination of inavolisib, palbociclib (Ibrance) and fulvestrant (Faslodex) got a breakthrough therapy designation from the FDA [1]. A positive moment for all patients with HR-positive, HER2-negative breast cancer with the PIK3CA mutation. This is a second breakthrough designation for this indication in 2024, following dato-DXd. 

While this gives hope to all patients and caretakers, it's not the same as an approval. When can we expect FDA, EMA, MHRA, and other approvals for inavolisib? Here's what you should know.

How does inavolisib work for breast cancer?

Inavolisib is an experimental medicine developed as a potent and selective inhibitor of the PI3K-alpha (phosphoinositide 3-kinase alpha) enzyme. PI3K-alpha plays a crucial role in cell growth and survival, particularly in cancer.

Inavolisib is designed to inhibit the PI3K pathway through HER2-dependent degradation. In this way, it aims to inhibit tumor growth in patients whose cancer is driven by PI3K mutations ². 

How effective is inavolisib in clinical trials?

Inavolisib has been studied in several clinical trials. The Phase 3 INAVO120 trial was focused on comparing the combination of inavolisib + palbociclib + fulvestrant against placebo + palbociclib + fulvestrant in treating PIK3CA-mutant, HR-positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer. The key reported results were:

• The median progression-free survival for patients in the inavolisib group was significantly higher than the placebo group (15.0 months versus 7.3 months);
• Patients taking inavolisib went 24 months before needing new treatment, compared to 15 months for those in the placebo group. This means that inavolisib may extend the time patients can stay on their current treatment without having to switch ³.

The results of the INAVO120 trial were the basis for the FDA's breakthrough therapy designation. It was also based on these reports that the FDA granted a priority review to inavolisib ³.

Is inavolisib approved somewhere?

 As of September 2024, not yet. However, decisions from the FDA, EMA and MHRA, among others, are expected within the foreseeable future. 

When is FDA approval expected for inavolisib?

The FDA granted a priority review to inavolisib and is expected to make an approval decision by November 27, 2024 ³. This of course does not mean that the decision will be positive. However, given the medicine's trial results so far, FDA approval seems like the most likely outcome. 

When will inavolisib get EMA approval?

Inavolisib's application for EMA approval has been in review since March 2024. Typically, approval decisions take up to 210 days, unless the EMA requires additional data from the medicine's manufacturer. If we assume there will be no delays with inavolisib's review, it could theoretically get a recommendation for approval somewhere in October 2024. If that happens, it takes up to three months for the EMA approval to become official. This potential timeline takes us to February 2025. 

After EMA approval, it can take between 3-4 months (in Germany) and almost 3 years (in Romania) until the medicine becomes available to patients across Europe ⁴. 

When will inavolisib be available in the UK?

It's difficult to say, as there is no active marketing authorization application for inavolisib in the UK. 

However, this doesn't have to mean it will take longer for the medicine to get MHRA approval. 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 ⁵. It wouldn't be surprising if the MHRA decides to take this road for approving inavolisib.

If that happens, then a review by NICE would be required to determine whether inavolisib will be included on the NHS. Assuming a positive outcome, it will take three further months from the day of the NICE's decision before inavolisib is available to patients in the UK. 

How to get inavolisib before it's approved in your country

Waiting for treatment can be challenging, especially without a clear timeline. The good news is, there are safe and legal ways to start your treatment with inavolisib before it's available in your country. 

One of your options is to find and join a clinical trial. Another option is to buy and import inavolisib for your personal use. The latter is possible as soon as the medicine gets approval somewhere in the world.

Here's how each option works.

Join a clinical trial

To get quick access to inavolisib, you can try joining an ongoing clinical trial. To do so, you must meet the eligibility criteria. You will also need your treating doctor's support. Good to keep in mind is that a trial doesn't guarantee you will be assigned to the treatment group. You may receive placebo instead.

Here are some good places to start looking for ongoing clinical trials:

• ClinicalTrials.gov: This is a database with all clinical trials in the USA. However, some of the trials are also open to international participants as well. At the moment, these inavolisib trials are recruiting patients worldwide. They may be worth keeping an eye on.
• EUClinicaltrials.eu: This database contains all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register.
• myTomorrows: This organization supports patients in finding treatment options in clinical trials.

Buy inavolisib as a Named Patient

In most countries, patients are legally allowed to buy and import medicines that could improve their lives or address life-threatening conditions. Specifically if these medicines are not approved or available locally yet.

If you want to access inavolisib before it's approved in Europe and the UK (or where you are located), this might be an option for you and your doctor. The regulation that makes this possible is known as Named Patient Import. Under this regulation, patients can import a medication not yet approved or available in their country if:

• it is approved elsewhere;
• it has no local alternatives, and
• it is for personal use.

This process requires a prescription from the patient’s treating doctor. Other documentation requirements may apply, depending on your country.

Do you want to use the Named Patient Import regulation to get inavolisib before its MHRA or EMA approval? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Share it with our team at Everyone.org, so we can support you with buying inavolisib as soon as it gets its first global approval. Wherever that may be. 

Get in touch

References:

1. Wahner, Ashling. Inavolisib Receives FDA Breakthrough Therapy Designation for PIK3CA-Mutated, HR+/HER2– Breast Cancer. OncLive, 21 May 2024.
2. Inavolisib - Wikipedia. Wikipedia. Accessed 10 September 2024.
3. Inavolisib Delays Progression, Time to Next Therapy in PIK3CA-Mutant Breast Cancer. Targeted Oncology, 1 June 2024.
4. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 10 September 2024.
5. Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.