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Lilly closes on first approval for sarcoma drug Lartruvo

Orphan drug improved patient survival time by almost 12 months in phase II trial

EMAEli Lilly could be just weeks away from EU approval of its advanced soft tissue sarcoma (STS) treatment Lartruvo after a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).

The EMA panel gave a green light to a conditional approval of Lartruvo (olaratumab), used in combination with doxorubicin chemotherapy, for advanced STS patients who cannot be treated with surgery or radiotherapy and have not previously been treated with doxorubicin.

Lilly said the recommendation is the "first global regulatory step towards approval for olaratumab," which is a platelet-derived growth factor receptor (PDGFR) alpha inhibitor and has been granted orphan status in the EU.

STS is a rare and complex form of cancer - with multiple subtypes - that is characterised by high levels of PDGFR alpha expression. It is thought that by binding to the receptor Lartruvo can slow down tumour growth. In 40-60% of cases STS is already at an advanced stage at diagnosis, and only around half of advanced STS patients live beyond five years.

"This prognosis has not improved over the last 40 years," said the CHMP in a statement. "Therefore new medicines are needed for patients."

In a phase II trial, the combination of doxorubicin plus Lartruvo was able to improve survival time by almost 12 months compared to doxorubicin alone. The conditional approval in the EU means that until the outcome of the ongoing phase III ANNOUNCE trial is known the drug will undergo an annual safety and efficacy review.

Olaratumab is also under regulatory review in the US and the FDA has given it priority review status, with a verdict due before the end of the year. Lilly acquired the antibody as part of its $6.5bn takeover of ImClone in 2008. The drug is one of 20 new molecular entities (NMEs) the pharma company intends to launch by 2023.

If approved, the drug will join other new therapies for STS, including Johnson & Johnson's chemotherapy agent Yondelis (trabectedin) and Eisai's Halaven (eribulin mesylate), both of which have been approved by the FDA in recent months for rare and aggressive STS subtypes.

Meanwhile, Nanobiotix filed for approval of its radio-enhancer drug NBTXR3 for STS in Europe last week, while CytRx has an improved doxorubicin candidate called aldoxorubicin in late-stage testing.

Article by
Phil Taylor

19th September 2016

From: Regulatory

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