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EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

EMA

The EU'S medicines regulator says doctors should stop prescribing Eli Lilly’s soft tissue cancer drug Lartruvo to new patients, because it failed a phase 3 trial intended to back up its accelerated approval in 2016.

Lilly claimed EMA approval for Lartruvo (olaratumab) for the first-line treatment of advanced soft tissue sarcoma (STS) in 2016, when it became the first new drug for patients with the disease in nearly four decades, based on phase 2 data in a fairly limited patient population.

Staying on the market depended on a confirmatory phase 3 trial, however, and earlier this month Lilly revealed that study – called ANNOUNCE – missed the mark. Lilly said at the time it would stop promoting Lartruvo and would book a $70m-$90m charge this quarter as a result.

This is the first time that the EMA has taken such an action on a product that has been granted a conditional approval. Meanwhile, the trial failure also impacts Lartruvo in the US, as the FDA also approved the drug early on the promise of follow-up data.

Lartruvo

Lartruvo was first approved in Europe in 2016

“Preliminary results from the ANNOUNCE study show that Lartruvo…in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone,” said the EMA in a statement.

“While full results from the study are awaited, EMA is recommending that no new patients should start treatment with the medicine,” although patient already on the drug can continue if their doctors thinks they are getting some benefit.

In ANNOUNCE, overall survival was barely better for Lartruvo plus doxorubicin versus doxorubicin alone, at 20.4 months versus 19.7 months which was a long way from a statistically-significant difference.

Progression-free survival (PFS) was better for doxorubicin alone, at 6.8 months compared to 5.4 months for the combination, although Lilly’s drug didn’t seem to add to patients’ side-effect burden.

Lartruvo hasn’t yet become a big earner for Lilly, but the company said last year it was pleased with the take-up of the drug and estimated it had achieved a 20% market share in STS in the US, with sales growing at more than 40% in the third-quarter to $77m, taking its tally for the year at that point to just over $220m.

The product was viewed as an important element in Lilly’s efforts to prop up its oncology franchise after the loss of patent protection for blockbuster Alimta (pemetrexed) in some markets, along with other newer cancer drugs such as Cyramza (ramucirumab).

The company took a further step down the oncology-building path earlier this month when it signed a deal to buy Loxo Oncology for $8bn to claim its just-approved Vikrakvi (larotrectinib) for NTRK gene fusion cancers.

24th January 2019

From: Regulatory

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