Please login to the form below

Not currently logged in
Email:
Password:

Lilly bags EU approval for cancer treatment Lartruvo

Licensed for use with doxorubicin for soft tissue sarcoma patients
Eli Lilly

The European Commission has granted Lilly's Lartruvo (orlaratumab) marketing authorisation for the first-line treatment of patients with advanced soft tissue sarcoma (STS).

The monoclonal antibody is the first of its kind to receive a licence for STS, and ended a four-decade drought for new frontline therapies in this area when it won FDA accelerated approval in October.

Awarded a conditional licence by European regulators, Lartruvo will be administered in combination with chemotherapy drug doxorubicin in previously untreated adults with advanced STS not eligible for curative surgery or radiotherapy.

The EC's decision was based on phase II data from the JGDG trial, which showed the combination almost doubled survival, extending it to 26.5 months compared to 14.7 for doxorubicin alone.

Having awarded an accelerated approval, the EMA has requested additional data from the ongoing ANNOUNCE phase III study which is due to generate results in 2019. Until then, Lartruvo will be subject to an annual safety review by the CHMP.

Dr Sue Mahony, president of Lilly Oncology, said: “With this decision, olaratumab is now authorised for use in the EU, offering a new treatment option for soft tissue sarcoma patients in Europe.

“This news further reinforces Lilly's ongoing commitment toward these types of rare diseases and the patients that are affected around the globe.”

Article by
Rebecca Clifford

11th November 2016

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Cello Health

Cello Health are expert navigators, helping healthcare clients uncover hidden insights, explore scientific options and make difficult strategic choices...

Latest intelligence

Spotlight interview: 15 minutes on insights and market research in pharma
Neil Rees, Head of Research, OPEN Health Patient & Brand Communication takes 15 minutes to answer some key questions on insights and market research in pharma...
WHITE PAPER: The increasing importance of clinical trial marketing advertising in patient recruitment
Learn why advertising is more important than ever in clinical studies...
The 'winner takes all' pricing game
Tendering has long been common in healthcare for medical devices and diagnostics; the Gulf Cooperation Council and the Jamaica Commodity Trading Company have been using pharmaceutical tendering since the 1970s....

Infographics