On 14 November 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product lazertinib (Lazcluze), intended in combination with amivantamab, for the treatment of non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
The applicant for this medicinal product is Janssen-Cilag International NV.
Lazcluze will be available as 80 mg and 240 mg film-coated tablets. The active substance of Lazcluze is lazertinib, an EGFR tyrosine kinase inhibitor (ATC code: L01EB09). Lazertinib selectively inhibits EGFR with exon 19 deletions and exon 21 L858R substitution mutations. By doing so, lazertinib inhibits the proliferation of cancer cells and promotes their death. Because lazertinib preferentially targets EGFR mutations, it minimises undesirable effects on normal cell functions typically associated with EGFR inhibition.
The benefit of first-line treatment with Lazcluze in combination with amivantamab is an improvement in progression-free survival compared with osimertinib monotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC not amenable to curative therapy.
The most common side effects are rash, nail toxicity, infusion-related reaction, hepatotoxicity, stomatitis, venous thromboembolism, paraesthesia, fatigue.
The full indication is:
Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Lazcluze should be prescribed by physicians experienced in the use of anticancer medicinal products.
EMA Recommends Extension of Indications for Amivantamab
On 14 November 2024, the EMA’s CHMP adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product amivantamab (Rybrevant).
The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.
The CHMP adopted a new indication as follows:
Rybrevant is indicated:
- in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.
For information, the full indications for Rybrevant will be as follows (new indication in bold):
Rybrveant is indicated:
- in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.
- in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor.
- in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.
- as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.
Detailed recommendations for the use of these products will be described in the summaries of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisations have been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.