Patients who have been taking a drug that is scheduled for withdrawal from the market after failing to show benefit in a clinical trial will still have access to it under an effort by the manufacturer.
Indianapolis-based Eli Lilly & Co. said Thursday that it would seen to ensure patients currently taking Lartruvo (olaratumab) for soft-tissue sarcoma can still receive the drug after it is withdrawn. The planned withdrawal follows the news in January that ANNOUNCE, a Phase III confirmatory trial the company had been conducting as a condition for the Food and Drug Administration’s 2016 accelerated approval, failed to show a benefit.
The accelerated approval was based on results of a randomized Phase II study of 133 patients that had shown the drug, when combined with the chemotherapy agent doxorubicin, improved overall survival compared with doxorubicin alone. ANNOUNCE, with 460 patients, would have led to full approval of the drug had it been successful.
Following the trial’s failure, the FDA and European Medicines Agency both recommended that doctors not initiate any new patients on the drug, while patients already on it consult with their doctors about whether to keep using it. The EMA, which issued its recommendation ahead of the FDA’s, estimated at the time that approximately 1,000 patients in the EU were being treated with Lartruvo. The EMA’s authority includes the EU as well as the European Economic Area nations of Norway, Iceland and Liechtenstein.
Despite the FDA and EMA recommendations, several clinical trials of Lartruvo remain listed as active on ClinicalTrials.gov. Of the 21 total trials, five are listed as currently recruiting, and one is listed as not yet recruiting. Of the ones that the site states are currently recruiting, two – one combining Lartruvo with Merck & Co.’s Keytruda (pembrolizumab) and another combining it with Celgene’s Abraxane (nab-paclitaxel) – are sponsored by Lilly and were last updated earlier this month. The trial listed as not yet recruiting, combining Lartruvo with AstraZeneca’s Imfinzi (durvalumab) and sponsored by Korea’s Yonsei University, was last updated in March.
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