NeedyMeds Back The medication, olaratumab, that was typed in the drug search is not offered under a pharmaceutical assistance program at this time.
Full Answer
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
What is the purpose of the study on olaratumab?
The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).
How long after olaratumab is it effective?
Females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. A highly effective method of birth control is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner.
How long does it take to get OS on olaratumab?
Results of ANNOUNCE, which was the confirmatory trial for the FDA approval of olaratumab in this setting, demonstrated that there was no difference in OS between the 2 arms. The median OS was 20.4 months with olaratumab/doxorubicin and 19.7 months with doxorubicin (HR, 1.05). In the leiomyosarcoma subpopulation, the median OS was 21.6 months and 21.9 months for olaratumab/doxorubicin and doxorubicin, respectively.
How much reduction in the risk of death with olaratumab and doxorubicin alone?
This approval was based on data from the phase II JGDG study, which demonstrated a 48% reduction in the risk of death with olaratumab and doxorubicin versus doxorubicin alone (HR, 0.52; 95% CI, 0.34-0.79, P <.05). 3 In the 133-patient, randomized, US trial, the median OS in the intent-to-treat population (n = 129) was 26.5 months with olaratumab/doxorubicin versus 14.7 months with doxorubicin alone.
Can Lilly continue treatment with olaratumab?
No new patients will be permitted to undergo treatment with olaratumab outside of ongoing clinical trials.
Can olaratumab be given with doxorubicin?
Additionally, the European Medicines Agency (EMA) issued a similar recommendation based on the negative findings of the confirmatory trial, stating that the combination of olaratumab and doxorubicin should not be administered in any new patients with advanced STS.4
