SECURA — Farydak FDA Summary Review (NDA/BLA 205353, 2015)
Secura Bio · 2015 · FDA Summary Review (Drugs@FDA)
Report summary
This report summarizes the FDA review of FARYDAK (panobinostat), a histone deacetylase inhibitor, for multiple myeloma (NDA 205353). FARYDAK's development and clinical trial results, primarily from Trial D2308, are detailed. While the drug demonstrated improved progression-free survival, its toxicity and limited benefit led to accelerated approval for a highly refractory patient population. The report also outlines the timeline and design of a Phase 3 randomized, placebo-controlled trial (PMR 2181-2). This trial compared panobinostat combined with bortezomib and dexamethasone against bortezomib and dexamethasone alone in relapsed multiple myeloma patients previously exposed to immunomodulatory agents, with progression-free survival as the primary endpoint.
Key findings — cited to the page
| Grade ≥3 thrombocytopenia (control arm) | 31 % | D2308 · p.12 |
| Grade ≥3 fatigue/asthenia (control arm) | 12 % | D2308 · p.12 |
| Grade 1-4 adverse events (control arm) | 99.7 % | D2308 · p.12 |
| Grade ≥3 thrombocytopenia (panobinostat arm) | 67 % | D2308 · p.12 |
| Grade ≥3 diarrhea (control arm) | 8 % | D2308 · p.12 |
| Grade ≥3 fatigue/asthenia (panobinostat arm) | 25 % | D2308 · p.12 |
| patients with Grade 3/4 adverse events | 87 % | · p.5 |
| Grade 1-4 adverse events (panobinostat arm) | 99.7 % | D2308 · p.12 |
| Grade ≥3 adverse events (panobinostat arm) | 95 % | D2308 · p.12 |
| Grade ≥3 adverse events (control arm) | 83 % | D2308 · p.12 |
| Grade ≥3 diarrhea (panobinostat arm) | 25 % | D2308 · p.12 |
| Grade ≥3 pneumonia (panobinostat arm) | 10 % | D2308 · p.12 |
Source: Secura Bio ↗ · 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 →