Olaratumab
Class: Antineoplastic Agents
- Platelet-derived Growth Factor Receptor (PDGFR) Alpha Inhibitors
- PDGF Receptor-α Inhibitors
- PDGFR-α Inhibitors
Chemical Name: Disulfide with human monoclonal 3G3 κ-chain, anti-(human platelet-derived growth factor receptor α) (human monoclonal 3G3 γ-chain), immunoglobulin G1, dimer
Molecular Formula: C6554H10076N1736O2048S40
CAS Number: 1024603-93-7
Brands: Lartruvo
Warning
Special Alerts:
Notice: On April 25, 2019, Lilly announced a worldwide withdrawal of olaratumab (Lartruvo) prompted by the failure of a phase 3 confirmatory study (ANNOUNCE) to verify clinical benefit of olaratumab in patients with locally advanced or metastatic soft tissue sarcoma.
Preliminary results from the ANNOUNCE study demonstrated no difference in overall survival in patients receiving olaratumab in combination with doxorubicin compared with those receiving doxorubicin alone.
Therapy may be continued only in patients currently receiving olaratumab therapy following consultation with their healthcare provider; do not initiate therapy in new patients outside of a controlled clinical trial. Contact the manufacturer at 877-285-4559 for information on the olaratumab expanded access program.
Introduction
Antineoplastic agent; recombinant human IgG1 monoclonal antibody that specifically binds to platelet-derived growth factor receptor alpha (PDGFR-α).
Uses for Olaratumab
Soft Tissue Sarcoma
Used in combination with doxorubicin for the treatment of soft tissue sarcoma that is not amenable to curative treatment with surgery or radiation therapy; patients must have a histologic subtype for which an anthracycline-containing regimen is appropriate (designated an orphan drug by FDA for treatment of this cancer ).
Accelerated approval was based on progression-free and overall survival. Continued approval was contingent on verification and description of clinical benefit in confirmatory studies.
Olaratumab Dosage and Administration
General
Consult respective manufacturers' labelings for information on dosage and method of administration of other antineoplastic agents used in combination regimens.
Administer in setting where resuscitation equipment is readily available.
Premedication for Infusion-related Reactions
Administer diphenhydramine hydrochloride 25–50 mg IV and dexamethasone phosphate 10–20 mg IV before olaratumab infusion on day 1 of cycle 1.
Restricted Distribution
Available only through an expanded access program. Consult manufacturer (Lilly) at 877-285-4559 for specific information. (See Special Alerts.)
Administration
IV Administration
For solution compatibility information, see Compatibility under Stability.
Administer by IV infusion. Do not administer by rapid IV injection (e.g., IV push or bolus).
Do
