Approval · Notice of Compliance 37731 · 2026
RYBREVANT: Notice of Compliance 37731
Issued June 18, 2026
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 37731
- Date
- June 18, 2026
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indications: Rybrevant (amivantamab for injection) is indicated: • in combination with lazertinib for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations. Rybrevant SC (amivantamab injection) is indicated: • in combination with lazertinib for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations. • in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib. • in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic NSCLC with activating EGFR Exon 20 insertion mutations. • as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RYBREVANT | Not yet assigned | — |
| RYBREVANT SC | 02569140 | Marketed |
| RYBREVANT SC | 02569159 | Marketed |
| RYBREVANT SC | 02569167 | Marketed |
| RYBREVANT SC | 02569175 | Marketed |
Medicinal ingredients
- AMIVANTAMAB 350 MG per 7ML
- AMIVANTAMAB 1,600 MG per 10ML
- AMIVANTAMAB 2,240 MG per 14ML
- AMIVANTAMAB 2,400 MG per 15ML
- AMIVANTAMAB 3,520 MG per 22ML