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Access Program to Be Established for Patients After Olaratumab Is Withdrawn From the Global Market


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ELI LILLY AND COMPANY recently announced that it has been working to facilitate the withdrawal of olaratumab from the market for the treatment of advanced soft-tissue sarcoma. Lilly’s actions to withdraw olaratumab from the market follow completion of the international phase III ANNOUNCE clinical trial (ClinicalTrials.gov identifier NCT02451943), in which the drug failed to improve survival for patients. Lilly presented the ANNOUNCE data at the 2019 ASCO Annual Meeting (Abstract LBA3).

Lilly is working to establish a program to ensure that patients who are currently receiving olaratumab may, in consultation with their physician, continue their course of therapy if they have been informed of the risks of olaratumab and the results of the ANNOUNCE study and wish to continue, subject to local laws and regulations. No new patients should receive olaratumab outside of participation in ongoing clinical trials.

ANNOUNCE Trial

ANNOUNCE was a randomized, double-blind, phase III study of olaratu-mab in combination with doxorubicin followed by olaratumab monotherapy vs doxorubicin plus placebo followed by placebo in patients with advanced soft-tissue sarcoma. The primary endpoints were overall survival in the intent-to-treat population and overall survival in the leiomyosarcoma subpopulation. Patients with locally advanced, unresectable, or metastatic soft-tissue sarcoma not amenable to curative treatment were enrolled and were eligible with any prior number of treatment regimens, provided they had not previously received treatment with an anthracycline.

Olaratumab was administered at a loading dose of 20 mg/kg on days 1 and 8 of cycle 1 and 15 mg/kg on days 1 and 8 of all subsequent cycles in combination with doxorubicin at 75 mg/m2 administered on day 1 of each cycle. Placebo was administered in combination with doxorubicin for 8 cycles. Olaratumab was continued as monotherapy until disease progression.

Olaratumab is a platelet-derived growth factor receptor alpha -(PDGFR-α)–blocking antibody. The drug exhibits in vitro and in vivo antitumor activity against selected sarcoma cell lines and disrupts the PDGFR-α signaling pathway in in vivo tumor implant models.

As approved by the U.S. Food and Drug Administration, olaratumab is indicated, in combination with doxorubicin, for the treatment of adult patients with soft-tissue sarcoma with a histologic subtype not amenable to curative treatment with radiotherapy or surgery, for which an anthracycline-containing regimen is appropriate. This indication received accelerated approval. Continued approval for this indication was contingent upon verification and description of clinical benefit in the confirmatory trial. 


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