Lilly soft tissue cancer drug gets EU nod

Eli Lilly’s Lartruvo (olaratumab) has been recommended by Europe’s regulator for adults with the rare cancer, soft tissue sarcoma.

Lartruvo is to be used in combination with doxorubicin in patients with advanced soft tissue sarcoma for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin.

The news that Lartruvo will almost certainly be approved in the EU is a welcome piece of good news for Eli Lilly, at a time when the company waits for its new CEO to take charge.

John Lechleiter is retiring at the end of the year and will be replaced by David Ricks, the head of the company’s biomedicines division.

Eli Lilly is looking to new approvals to boost sales after several big-selling medicines lost patent protection in recent years, such as the antidepressant Cymbalta (duloxetine).

The European Medicines Agency’s CHMP scientific committee accelerated the assessment of Lartruvo and recommended a conditional approval based on early data.

This means the benefits and safety of the drug will be reviewed each year until late-stage data is ready.

The CHMP’s recommendation is based on phase 2 data from the JGDG trial, showing a significant improvement in the time patients survived with a combination of doxorubicin, plus Lartruvo compared to doxorubicin alone – a median gain of 11.8 months.

Lilly must provide data from an ongoing phase 3 ANNOUNCE study to make the marketing authorisation permanent.

The US Food and Drug Administration has also granted a fast review for the drug, following a filing in May.

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. This means it may cause anticancer activity by targeting tumour cells directly, as well as cells that surround and support tumour growth.

The CHMP’s decision will be passed to the European Commission, which will likely recommend a marketing authorisation in the coming weeks.

 

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