Padcev
Oncology· 2672 cited findings· 4 source documents
Company: Astellas Pharma Inc.
What the regulatory reviews say
Padcev (enfortumab vedotin-ejfv) is a BLA-approved drug that received Priority Review. The application was submitted and received on July 15, 2019, with a PDUFA Goal Date of March 15, 2020, and a Review Completion Date of December 17, 2019.
In clinical trials, Padcev demonstrated an Objective Response Rate (ORR) of 32.2%, with a Median Duration of Response (DOR) of 5.4 months. The Median Overall Survival (OS) was 6.9 months, and Median Progression-Free Survival (PFS) was 3.0 months. For comparison, median OS for carboplatin-based therapy in clinical trials was 9 to 11 months, and for cisplatin-containing therapy, it was 13 to 14 months. The ORR for vinflunine in second-line treatment was 8.6%. In a trial comparing pembrolizumab to chemotherapy (paclitaxel, docetaxel, or vinflunine), the OS benefit was 10.3 months versus 7.4 months, with a Hazard Ratio of 0.73 (95% CI: 0.59–0.91).
Notable safety findings include Lipase increased (Grade 3-4) at 9% and Hyperglycemia (all grades) at 14.5%. ALT increased (all grades) was observed in 34% of patients.
Key figures — cited to the source page
| Objective Response Rate (ORR) | 32.2 | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.24 |
| Median Duration of Response (DOR) | 5.4 | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.24 |
| Median Overall Survival (OS) | 6.9 | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.25 |
| Median OS for carboplatin-based therapy | 9 to 11 | Astellas Pharma Inc. — Padcev EMA EPAR variation assessment, p.9 |
| Median OS for cisplatin-containing therapy | 13 to 14 | Astellas Pharma Inc. — Padcev EMA EPAR variation assessment, p.9 |
| Lipase increased (Grade 3-4) | 9 | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.211 |
| Hyperglycemia | 14.5 | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.219 |
| Application Type | BLA | Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1,, p.2 |
Source documents
- Astellas Pharma Inc. — Padcev EMA EPAR public assessment report (EMEA/H/C/005392, 2022) (2022)
- Astellas Pharma Inc. — Padcev EMA EPAR variation assessment report (EMEA/H/C/005392, 2022) (2022)
- Astellas Pharma Inc. — Padcev EMA EPAR variation assessment report (EMEA/H/C/005392, 2022) (2022)
- Astellas Pharma Inc. — Padcev FDA Review (BLA761137, ORIG 1, 2019) (2019)
Explore the full evidence
All 2672 cited findings for Padcev — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.