← FDA DRUG APPROVALS

FDA BLA · BLA761291

TECVAYLI

teclistamab-cqyv

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761291
TYPE
BLA
ORIGINAL APPROVAL
2022-10-25
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TECVAYLIPrescription
TECLISTAMAB-CQYV 30MG/3ML(10MG/ML) · INJECTABLE · INJECTION
TECVAYLIPrescription
TECLISTAMAB-CQYV 153MG/1.7ML(90MG/ML) · INJECTABLE · INJECTION

Approval history

2026-05-06REMS · Supplement 17 — Letter ↗AP
2026-03-05Efficacy · Supplement 18 · priority — Letter ↗AP
2025-10-02REMS · Supplement 15 — Letter ↗AP
2025-08-19Labeling · Supplement 13 · standard — Letter ↗AP
2024-12-02REMS · Supplement 11 — Letter ↗AP
2024-11-22Efficacy · Supplement 9 · standard — Letter ↗AP
2024-07-02REMS · Supplement 7AP
2024-05-28Labeling · Supplement 8 · standard — Letter ↗AP
2024-02-20Efficacy · Supplement 3 · standard — Letter ↗AP
2023-11-16REMS · Supplement 5 — Letter ↗AP
2023-08-09REMS · Supplement 4 — Letter ↗AP
2022-10-25Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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