ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019)
Eli Lilly and Company · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
Eli Lilly's Lartruvo (olaratumab) received accelerated FDA approval on July 10, 2017, for adult soft tissue sarcoma patients, in combination with doxorubicin. This approval was based on Trial 1, which showed a significant overall survival benefit (26.5 months vs. 14.7 months) for the Lartruvo combination. The FDA also approved a supplemental biologics license application (sBLA) for Lartruvo, introducing a new 190 mg/19 mL vial presentation. This new presentation was deemed analytically comparable to the existing 500 mg/50 mL dosage, with manufacturing changes considered low risk.
Key findings — cited to the page
| LARTRUVO dose reduction due to Grade 3 or 4 neutropenia | 20 % | Trial 1 · p.7 |
| Grade >=3 IRR rate | 2.3 % | · p.7 |
| IRR leading to permanent discontinuation | 2.3 % | · p.7 |
| Patients with Grade 1 or 2 IRR on rechallenge | 12 (20%) | · p.7 |
| Patients with Grade 1 or 2 IRR resuming LARTRUVO | 59 | · p.7 |
| IRR leading to infusion interruption | 10 % | · p.7 |
| Infusion-related reactions (IRR) rate | 14 % | · p.7 |
| Recommendation | approval | Olaratumab · p.9 |
| Action Due Date | 7/13/2017 | Olaratumab · p.9 |
| Indication | Lartruvo is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. | LARTRUVO (olaratumab) · United States · p.1 |
| Previously approved vial presentation | 500 mg/50 mL | Olaratumab · p.12 |
| New vial presentation | 190 mg/19 mL | Olaratumab · p.12 |
Source: Eli Lilly and Company ↗ · 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 →