lilly_entrance_web

EU recommendation for Lilly’s soft tissue cancer drug

pharmafile | September 19, 2016 | News story | Sales and Marketing CHMP, EMA, Eli Lilly, Lartruvo, soft tissue sarcoma 

The Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Lartruvo (olaratumab) for treatment of adults with the rare cancer, soft tissue sarcoma.

Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-α (platelet-derived growth factor receptor α) pathway on tumour cells and on cells in the tumour microenvironment.

The pharma firm’s drug is to be used in combination with doxorubicin for treatment of the illness for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin.  

Advertisement

The FDA also fast-tracked review of the treatment in May.

The recommendation is based on data from Phase II of the JGDG study which showed a median improvement of 11.8 months in survival time of patients treated with a combination of doxorubicin plus Lartruvo compared to doxorubicin alone. The decision is thought to strongly encourage a marketing authorisation in the coming weeks.

Matt Fellows

Related Content

Rethinking oncology trial endpoints with generalised pairwise comparisons

For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …

Lilly opens fourth US Gateway Labs site

Eli Lilly has opened its newest Lilly Gateway Labs (LGL) site in San Diego, California, …

brain-770044_960_720

Lilly’s drug for early Alzheimer’s shows promising results

Eli Lilly (Lilly) has announced positive new data from the long-term extension of its phase …

The Gateway to Local Adoption Series

Latest content