FdaApplication
BLA 125746
Identifiers
- fda_app_no: BLA125746
Properties
| Property | Value |
|---|---|
| applicant_name | Janssen Biotech, Inc. |
| application_type | BLA |
| approval_date | 2022-02-28 |
Revenue by product
CARVYKTI
| Period | Revenue |
|---|---|
| Q2 2026 | $657.0M |
| Q1 2026 | $597.0M |
| Q4 2025 | $555.0M |
| Q3 2025 | $524.0M |
| Q2 2025 | $439.0M |
| Q1 2025 | $369.0M |
| Q4 2024 | $334.0M |
| Q3 2024 | $286.0M |
| Q2 2024 | $186.0M |
| Q1 2024 | $157.0M |
| Q4 2023 | $159.0M |
| Q3 2023 | $152.0M |
| Q2 2023 | $117.0M |
| Q1 2023 | $72.0M |
| Q4 2022 | $54.0M |
| Q3 2022 | $55.0M |
| Q2 2022 | $24.0M |
| Q1 2022 | $0.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARVYKTI | — | 0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion | For Injection |
1 product