PHARMACYCLICS LLC — Imbruvica FDA Summary Review (NDA/BLA 205552, 2015)
AbbVie Inc. · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
This document summarizes the FDA's review of Pharmacyclics' New Drug Application (NDA) for ibrutinib (Imbruvica) for chronic lymphocytic lymphoma (CLL). Submitted on June 28, 2013, the application proposed a 420 mg oral dose once daily. The FDA granted accelerated approval based on a single-arm trial, with post-marketing commitments for confirmatory studies.
Key findings — cited to the page
| NDA filing date | June 28, 2013 | ibrutinib · p.3 |
| Trial design | ongoing, open-label, single-arm trial | PCYC-1102-CA · p.3 |
| Number of patients | 48 | PCYC-1102-CA · p.3 |
| Dosing regimen | 420 mg once daily | ibrutinib · p.3 |
| PDUFA goal date | February 28, 2014 | · p.3 |
| Estimated CLL diagnoses | 15,680 | · p.4 |
| Median exposure duration | 15.6 months | · p.7 |
| Patients with at least 1 treatment-emergent adverse event | All | · p.7 |
| Patients with at least one bleeding event | 58 % | · p.7 |
| Patients experiencing petechiae | 17 % | · p.7 |
| Patients requiring dose modification or interruption due to AE | 42 % | · p.7 |
| Most common AE leading to modification/interruption (infections) | 19 % | · p.7 |
Source: AbbVie Inc. ↗ · 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 →