Lazertinib's EMA approval: When will it be available in Europe, the UK, and worldwide?

Non-small cell lung cancer (NSCLC) patients are likely familiar with the T790M mutation. This mutation often appears in later stages of NSCLC, after patients have been treated with EGFR tyrosine kinase inhibitors (TKIs). The T790M causes resistance to TKI treatments, thus limiting the options for patients and doctors.

In this context, the emergence of Leclaza (lazertinib) as a third-generation TKI brings hope to those who may have run out of treatment options.

With approval applications still under review, when will lazertinib be available in Europe, the UK, and worldwide? Here's everything you need to know.

What is lazertinib used for?

Leclaza (lazertinib) is developed as a second-line treatment for T970M mutation-positive NSCLC, alone or in combination with Rybrevant (amivantamab). The medicine is also used as a first-line treatment for EGFR-mutated NSCLC - either as monotherapy or in combination with amivantamab ¹.

Note that these indications are currently only approved in South Korea ¹.

How effective is lazertinib in clinical trials?

To understand the potential of lazertinib as an NSCLC treatment, let's review the reported results from clinical studies available so far.

Lazertinib as monotherapy in EGFR-mutated NSCLC

In the international LASER301 study, patients who had received no previous systematic anticancer therapy were either given lazertinib or gefitinib.

The reported results were:

• Median progression-free survival was 20.6 months with lazertinib and 9.7 months with gefitinib;
• 76% of patients in both groups either had a stable disease or responded to the treatment;
• Median duration of response was 19.4 months with lazertinib and 8.3 months with gefitinib;
• The 18-month survival rate was 80% with lazertinib and 72% with gefitinib ².

Lazertinib with Rybrevant in EGFR-mutated NSCLC

In the Phase 3 MARIPOSA trial, lazertinib was used in NSCLC patients who hadn't been treated before and who had the EGFR mutation. They were assigned to received lazertinib with Rybrevant or osimertinib only.

The reported results were:

• Patients treated with lazertinib + amivantamab showed a 30% reduction in the risk of disease progression or death, as compared to those receiving osimertinib;
• Progression-free survival for lazertinib + amivantamab patients was 23.7 months vs 16.6 months for osimertinib patients;
• The median duration of response with lazertinib + amivantamab was 25.8 months vs 16.8 months for osimertinib ³.

Lazertinib as a second-line treatment for T970M-mutated NSCLC

In a retrospective study among 103 Korean patients treated with lazertinib after testing positive for an EGFR T970M mutation, these results were reported:

• 72.8% of patients had stable disease or responded to the treatment;
• The progression-free survival rate at the 6th and 12th month follow-up points were 81.7% and 65.1%, respectively ⁴.

Based on the available data on lazertinib as a first- and second-line treatment for NSCLC, it's clear that the medicine has potential. However, more data are needed to confirm Leclaza's second-line performance in a larger-scale, international study with a different design.

Where is lazertinib approved?

As of May 2024, lazertinib is only approved in South Korea. It has full approval as a first-line treatment for EGFR-mutated NSCLC. As a second-line treatment for T970M-mutated NSCLC. lazertinib has conditional approval ¹.

In December 2023, Leclaza's manufacturer, Janssen Pharmaceuticals, submitted marketing authorization applications to the FDA and the EMA. In both cases, the applications are for the use of lazertinib with Rybrevant as a first-line treatment of EGFR-mutated NSCLC ⁵.

Lazertinib's EMA approval: What's the status?

The official application acceptance date for lazertinib's approval in the EU was 1st February 2024. From that date onwards, it typically takes the CHMP 210 days to make an approval decision. This takes us to September 2024. And if the CHMP makes a positive recommendation then? Lazertinib's EMA approval should become official within 67 days from that date.

Based on this estimated timeline, lazertinib's approval in the EU can be expected in late 2024 or early 2025.

When will lazertinib be available in Europe?

Unfortunately, getting EMA approved is only the first step. It doesn't mean that Leclaza will be immediately available for patients throughout the EU.

After EMA approval, it takes each member state a different amount of time to negotiate local prices, reimbursements, and launch a new medicine on the local market. Germany's launch process tends to be the fastest, with an average of 100 days for oncological drugs. At the other end of the spectrum is Romania, where it can take up to 964 days on average for a new medicine to become available.

This means that lazertinib will become available to you at a different time, depending on where in Europe you are based ⁶. It could be as early as mid-2025 or as late as 2028.

When will lazertinib be approved in the UK?

That's more difficult to say. As of May 2024, there is no marketing authorization submitted to the MHRA for Leclaza (lazertinib). However, according to post-Brexit regulations, the MHRA can decide to 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. It wouldn't be surprising if the MHRA decides to take this road for approving lazertinib.

When will Leclaza be available in the UK?

If the MHRA approves lazertinib simultaneously with the EMA, expected around September 2024, the medicine will then require a NICE assessment before becoming available to patients in the UK. NICE will decide whether to include lazertinib in the NHS. If approved, the medicine should be available to UK patients within three months of the decision date.

NICE has initiated two evaluations at this moment. One is for lazertinib with amivantamab as a first-line therapy for EGFR-mutated NSCLC. The other is for lazertinib with amivantamab and chemotherapy as a second-line treatment for T790M-mutated NSCLC. Neither evaulation has an indicated decision date ^8,9.

Assuming the best-case scenario, where the MHRA follows a potential EMA approval in Septemer 2024, and NICE makes a positive decision soon after, lazertinib could be available in the UK by late 2024 or early 2025.

How to get lazertinib before its FDA, EMA or MHRA approval

Despite what the timelines above suggest, waiting is not the only option for lung cancer patients in Europe, the UK, or anywhere else.

Since the medicine is already approved somewhere (in South Korea), you can immediately access it anywhere else by importing it for your personal use. This option is known as Named Patient Import, or expanded access. Here's how it works.

Lazertinib expanded access

Even if a medicine is not yet approved or available in your country, you can legally access it. A regulation known as Named Patient Import allows you to buy and import a medicine, as long as it meets these conditions:

• it is approved somewhere;
• it is not approved or available in your country (yet);
• it has no local alternatives, and
• it is for personal use.

This process requires a prescription from your treating doctor. As in all other cases, the doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to start your treatment with lazertinib as soon as possible, using the Named Patient Import regulation? Share your prescription with our team at Everyone.org. We can support you with buying lazertinib immediately.

References:

1. Yuhan secures full approval for Leclaza as 1st-/2nd-line treatment for NSCLC. KBR, 11 December 2023.
2. Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301. PubMed, 10 September 2023.
3. LBA14 Amivantamab plus lazertinib vs osimertinib as first-line treatment in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results from MARIPOSA, a phase III, global, randomized, controlled trial. Annals of Oncology, October 2023.
4. Real-world clinical evidence of lazertinib use in acquired EGFR T790M mutated non-small cell lung cancer. Translational Lung Cancer Research, Accessed 27 May 2024.
5. Yuhan’s lung cancer drug Leclaza takes first step into global market. Korea Biomedical Review, 22 December 2023.
6. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 28 May 2024.
7. Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.
8. Lazertinib with amivantamab and platinum-based chemotherapy for EGFR mutation-positive metastatic non-small-cell lung cancer after a tyrosine kinase inhibitor TS ID 11822. NICE, Accessed 27 May 2024.
9. Amivantamab with lazertinib for untreated EGFR mutation-positive advanced non-small-cell lung cancer ID6256. NICE, Accessed 27 May 2024.