Patients with soft tissue sarcoma in England and Wales look set to win routine NHS access to Eli Lilly’s Lartruvo after cost regulators backed funding for the drug in draft guidelines.
Lartruvo (olaratumab) in combination with doxorubicin has been recommended by the National Institute for Health and Care Excellence for use as an option for advanced soft tissue sarcoma in adults who have not had any previous systemic chemotherapy for advanced soft tissue sarcoma and cannot have curative treatment with surgery or their disease does not respond to radiotherapy.
The Final Appraisal Determination was published one month earlier than expected, and is one of the first medicines to be made available within the new Cancer Drugs Fund, as well as the first monoclonal antibody to be recommended in combination with doxorubicin to treat the condition, Lilly noted.
Lartruvo was granted conditional marketing authorisation by the European Medicines Agency in November 2016 for use alongside the chemotherapy based on Phase II data showing a median survival gain of 11.8 months in those taking the combination versus the latter alone.
Patients treated with the Lartruvo/doxorubicin combo achieved 8.2 months of median PFS compared to 4.4 months on the doxorubicin-only arm, while the objective response rate was 18.2 percent versus 7.5 percent, respectively.
As part of a conditional marketing authorisation, Lilly will need to provide data from its ongoing Phase III study ANNOUNCE, which has fully enrolled with follow-up is underway. Until this data is available, the CHMP will review the benefits and risks of the drug annually to determine whether the conditional marketing authorisation can be maintained.
Forty to sixty percent of patients with STS will be in an advanced stage of the disease, and only half will live longer than five years under currently available treatment. This prognosis has not changed over the last forty years, highlighting the urgent need for new and more effective options.
“Olaratumab is a promising new treatment option for patients with advanced soft tissue sarcoma and I’m delighted to hear it will be available to NHS patients,” said Dr. Robin Jones, consultant medical oncologist and head of the Sarcoma Unit at The Royal Marsden and Team Leader at The Institute of Cancer Research, London, and an investigator of the registration trial.