Eli Lilly withdraws cancer drug Lartruvo from all markets
Eli Lilly is to withdraw its cancer drug Lartruvo from all markets after a late-stage trial showed it did not improve survival, although existing patients can continue receive it under an access programme.
The US pharma announced in January that no new patients should take the soft tissue sarcoma drug, and Lilly also stopped promoting it following the shock failure of the phase 3 ANNOUNCE clinical trial.
ANNOUNCE was supposed to confirm findings of a smaller mid-stage trial that were used for a fast approval in 2016 in the US and Europe.
But the writing was on the wall for Lartruvo (olaratumab) after ANNOUNCE failed to meet its two main survival goals, using standard chemotherapy as a comparator in patients with advanced or metastatic disease.
Lilly needed the drug to improve overall survival in the overall population and in a group of patients with leiomyosarcoma, for the trial to be considered a success.
Ever since then Lilly has been working with the FDA and the European Medicines Agency to determine the next steps for Lartruvo and has decided to pull it from the global market completely.
Lilly said programmes will ensure current patients still have Lartruvo reimbursed and prescribed, in line with local laws and regulations.
The Indianapolis-based pharma said that patients currently receiving Lartruvo should be able to continue to do so, in consultation with their physician as long as they have been informed of the risks of Lartruvo and the results of ANNOUNCE.
Lilly said it plans to present the ANNOUNCE data at the American Society of Clinical Oncology (ASCO) annual meeting in early June.
Anne White, president, Lilly Oncology, said: “Lilly wants to ensure that patients and physicians feel supported during this important time.
“Advanced soft tissue sarcoma is a rare and difficult-to-treat cancer. Establishing this programme will give patients who are currently taking Lartruvo the opportunity to continue their treatment program uninterrupted.”
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