Gilead Sciences, Inc. — Trodelvy FDA Review (BLA761115, ORIG 1, 2020)
Gilead Sciences, Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of Sacituzumab Govitecan (TRODELVY) for metastatic triple-negative breast cancer (mTNBC) led to accelerated approval based on the IMMU-132-01 trial. This trial demonstrated a 33.3% objective response rate and a 7.7-month median duration of response in heavily pre-treated patients. While efficacy was compelling, supported by the early halt of confirmatory trial IMMU-132-05, the initial BLA received a Complete Response Letter due to manufacturing and controls (CMC) deficiencies. Safety concerns included neutropenia and diarrhea, leading to a Boxed Warning. Despite some data inconsistencies at one clinical site, overall data reliability was affirmed. Post-marketing requirements include studies on hepatic impairment, QTc prolongation, and UGT1A1 status.
Key findings — cited to the page
| incidence of Grade 4 neutropenia in UGT1A1*28 homozygous patients | 27 % | IMMU-132-01 · p.154 |
| incidence of Grade 4 neutropenia in UGT1A1*28 heterozygous patients | 6 % | IMMU-132-01 · p.154 |
| dry skin (all grade) in efficacy population | 13.9 % | IMMU-132-01 · p.263 |
| dry skin (Grade 3-4) in safety population | 0.2 % | IMMU-132-01 · p.263 |
| dysgeusia (all grade) in safety population | 7.1 % | IMMU-132-01 · p.263 |
| dysgeusia (Grade 3-4) in safety population | 0 % | IMMU-132-01 · p.263 |
| objective response rate (ORR) for Ixabepilone (IRR assessment) | 12.4 % | · p.162 |
| Grade 3-4 AEs | 70.3 % | IMMU-132-01 · p.154 |
| upper respiratory tract infection (Grade 3-4) in efficacy population | 0.9 % | IMMU-132-01 · p.262 |
| dry skin (all grade) in safety population | 7.4 % | IMMU-132-01 · p.263 |
| dry skin (Grade 3-4) in efficacy population | 0.9 % | IMMU-132-01 · p.263 |
| incidence of Grade 4 neutropenia in UGT1A1 wild-type homozygous patients | 5 % | IMMU-132-01 · p.154 |
Source: Gilead Sciences, 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 →