BLA 761145, held by Janssen Biotech. Daratumumab And Hyaluronidase-Fihj.
As of Nov 13, 2026, BLA 761145 (Darzalex Faspro), held by Janssen Biotech, was first approved by FDA on May 1, 2020, with 14 approved supplements and 0 published complete response letters.
DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple …
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2026 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2025 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2025 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2024 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Nov 30, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jul 9, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jan 15, 2021 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jan 11, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2020 | Original applicationTYPE 3/4 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Darzalex Faspro120MG;2000UNITS/ML · injectable;injection | Daratumumab And Hyaluronidase-Fihj | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2026 | Supplement 39Labeling · Standard review | Approved | |
| Jan 27, 2026 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2025 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2025 | Supplement 35Labeling · Standard review | Approved | |
| Nov 6, 2025 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2024 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Nov 2, 2022 | Supplement 18Labeling · Standard review | Approved | |
| Jan 21, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Nov 30, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jul 9, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 12, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Feb 8, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jan 15, 2021 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jan 11, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2020 | Original applicationTYPE 3/4 · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
