Rybrevant (amivantamab)
- Region
- 🇪🇺 EU
- Active substance
- amivantamab
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 14 Oct 2021
- EU approval
- Thu 09 Dec 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005454
- ATC
- L01FX18
- Official record
- www.ema.europa.eu
Indication
Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (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 (TKI). 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇺🇸 Rybrevant Faspro Approved · Janssen Biotech
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.