Positive Opinion is the First Global Regulatory Step Towards Approval for Olaratumab
INDIANAPOLIS, Sept. 16, 2016 /PRNewswire/ -- Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of a conditional marketing authorisation for olaratumab, in combination with doxorubicin, for the treatment of adults in the European Union (EU) with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin. The CHMP reviewed olaratumab under EMA's accelerated assessment program. If approved, olaratumab will be marketed under the trade name LARTRUVO(TM).
This is the first regulatory step in the world towards approval for olaratumab. The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing authorisation in the EU. The Commission usually makes a decision on marketing authorisation within two to three months of the CHMP issuing its recommendation.
"Patients with advanced soft tissue sarcoma have been seeking new treatment options that can potentially extend lives, so they can have more time with their families and loved ones," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients."
This will be Lilly's first conditional approval in the EU. As part of a conditional marketing authorisation, Lilly will need to provide results from an ongoing Phase 3 study. This study, ANNOUNCE, is fully enrolled. Until availability of the full data, the CHMP will review the benefits and risks of olaratumab annually to determine whether the conditional marketing authorisation can be maintained.
The EMA previously granted olaratumab with Orphan Drug Designation for the treatment of advanced soft tissue sarcoma in the EU.
The EU submission is based on data from Phase 2 JGDG, an open-label, randomised trial that compared olaratumab, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. The primary study endpoint was progression-free survival (PFS), and key secondary endpoints included overall survival (OS) and objective response rate (ORR).
Lilly has also submitted the results of this study to the U.S. Food and Drug Administration (FDA) for regulatory review. The FDA recently granted Lilly Priority Review status for olaratumab. Lilly also has received additional designations for olaratumab from the FDA for this indication, including Breakthrough Therapy, Fast Track and Orphan Drug.
Notes to EditorAbout Olaratumab Olaratumab is a PDGFR blocking antibody that specifically binds PDGFR and prevents receptor activation. Olaratumab exhibited in vitro and in vivo anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFR signaling pathway in in vivo tumor implant models. Information about additional clinical trials for olaratumab in sarcoma can be found at ClinicalTrials.gov [https://clinicaltrials.gov/ct2/home] (in the search box on the home page, type in "olaratumab").
A Phase 3 trial of olaratumab and doxorubicin in advanced STS is fully enrolled (ClinicalTrials.gov Identifier: NCT02451943 [https://clinicaltrials.gov/ct2/show/NCT02451943?term=olaratumab&rank=2]).
About the JGDG Trial The open-label, randomized Phase 1b/2 study, JGDG, compared olaratumab in combination with doxorubicin chemotherapy to the control arm of doxorubicin alone in patients with unresectable, advanced STS not amenable to curative treatment with surgery or radiotherapy. After confirmation of safety in the Phase 1b portion of the study, 133 doxorubicin-naïve patients were randomized 1:1 in the Phase 2 portion of the study. A total of 66 patients were treated on the olaratumab-doxorubicin arm, and 67 on the placebo-doxorubicin arm. The primary endpoint of the study was PFS. Key secondary endpoints included OS and objective response rate (ORR).
Randomisation was balanced by ECOG performance status, histological tumor type, PDGFR expression and previous lines of treatment.
Patients treated on the olaratumab and doxorubicin arm achieved 6.6 months of median PFS compared to 4.1 months on the placebo and doxorubicin arm (stratified hazard ratio [HR], 95 percent confidence interval [CI]: 0.672 [0.442-1.021]; p=0.0615). The investigator-assessed PFS was confirmed by independent review (HR=0.670; 95 percent CI: [0.04-1.12]; p=0.1208) with a median PFS of 8.2 months vs. 4.4 months. OS was statistically significant, with patients treated on the olaratumab and doxorubicin arm having achieved a median OS of 26.5 months (95 percent CI, 20.9-31.7) compared to 14.7 months (95 percent CI, 9.2-17.1) with doxorubicin (stratified HR, 0.463; 95 percent CI, 0.301-0.710; p=0.0003). The ORR was 18.2 percent (95 percent CI; [9.8-29.6]) with olaratumab plus doxorubicin and 11.9 percent (95 percent CI: [5.3-22.2]) with doxorubicin (p=0.3421).
The most common (greater than 5 percent incidence) grade 3 or higher adverse events identified in the study were neutropenia (53.2 percent on the olaratumab combination arm vs. 32.3 percent on the placebo plus doxorubicin arm), anemia (12.5 percent vs. 9.2 percent), fatigue (9.4 percent vs. 3.1 percent) and musculoskeletal pain (8 percent vs. 2 percent). There were no increases in febrile neutropenia (12.5 percent on the olaratumab-doxorubicin arm vs. 13.8 percent on the placebo-doxorubicin arm), infections (7.8 percent vs. 10.8 percent) and patient discontinuations (13 percent vs. 19 percent). Grade 3 or higher infusion-related reactions occurred in 3 percent of patients on the olaratumab-doxorubicin arm vs. 0 percent on the placebo-doxorubicin arm.
About SarcomasSarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. STS is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. For decades, there have been no front-line therapeutic advancements for advanced STS that have improved overall survival. An estimated 23,000 people in the EU will be diagnosed with STS this year.
About Lilly OncologyFor more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.
About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com [http://www.lilly.com/] and newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].
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