EMD SERONO INC — Bavencio FDA Review (NDA/BLA 761049, 2020)
Merck KGaA · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved EMD Serono's Bavencio (avelumab) on June 30, 2020, for the maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval, based on the JAVELIN Bladder 100 study, demonstrated significant overall survival benefit with avelumab plus best supportive care (BSC) compared to BSC alone. The multidisciplinary review covered regulatory information, clinical pharmacology, and detailed safety and efficacy data from trials including JAVELIN Merkel 200, JAVELIN Bladder 100, and JAVELIN Renal 101. Bavencio's safety profile, consistent with known toxicities, included immune-mediated adverse reactions, with some higher risks observed in patients with treatment-induced anti-drug antibodies. The report also addressed dosing, administration, and immunogenicity.
Key findings — cited to the page
| Fatigue (Grade 3-4) in JAVELIN Merkel 200 | 2 % | JAVELIN Merkel 200 · p.26 |
| Peripheral edema (Grade 3-4) in JAVELIN Merkel 200 | 0 % | JAVELIN Merkel 200 · p.26 |
| Arthralgia (Grade 3-4) in JAVELIN Merkel 200 | 1 % | JAVELIN Merkel 200 · p.26 |
| Fatigue (all grades) in JAVELIN Merkel 200 | 50 % | JAVELIN Merkel 200 · p.26 |
| Infusion-related reaction (Grade 3-4) in JAVELIN Merkel 200 | 0 % | JAVELIN Merkel 200 · p.26 |
| Peripheral edema (all grades) in JAVELIN Merkel 200 | 20 % | JAVELIN Merkel 200 · p.26 |
| Grade 4 pneumonitis incidence | 0.1 % | · p.20 |
| Grade 3 pneumonitis incidence | 0.3 % | · p.20 |
| Grade 3-4 myocardial infarction (BAVENCIO with axitinib) | 2.8 % | · p.24 |
| Grade 3-4 congestive heart failure (BAVENCIO with axitinib) | 1.8 % | · p.24 |
| Infusion-related reaction (all grades) in JAVELIN Merkel 200 | 22 % | JAVELIN Merkel 200 · p.26 |
| Musculoskeletal pain (all grades) in JAVELIN Merkel 200 | 32 % | JAVELIN Merkel 200 · p.26 |
Source: Merck KGaA ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →