Eli Lilly has picked up its first green light for its soft tissue sarcoma (STS) therapy Lartruvo, ending a four-decade drought for new front-line therapies.
The US FDA granted accelerated approval to Lartruvo (olaratumab) used in combination with doxorubicin chemotherapy in STS patients who cannot be cured using surgery or radiotherapy, and who have a form of the cancer that does not usually respond well to chemotherapy.
The drug is likely only weeks away from approval in Europe too, after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on its use in STS last month.
The FDA’s director of haematology and oncology products, Richard Pazdur, said Lartruvo is the first new type of therapy approved by the FDA for the initial treatment of soft tissue sarcoma “since doxorubicin’s approval more than 40 years ago”.
Another drug – Johnson & Johnson’s Yondelis (trabectedin) – was approved in 2015 for two specific types of STS (liposarcoma and leiomyosarcoma). These account for around a third of the 50 subtypes of this form of cancer, which develops in muscles, fat, tendons or other soft tissues such as blood vessels. It was cleared as a second-line therapy after doxorubicin.
The National Cancer Institute estimates that around 12,000 new cases of STS occur a year, leading to nearly 5,000 deaths.
The US approval is based on the results of the phase II JGDG trial, which showed that patients who received Lartruvo with doxorubicin had a median survival of 26.5 months compared to 14.7 months for patients who received doxorubicin alone.
Lartruvo has been given a conditional approval by the FDA, so Lilly will have to provide confirmation in an ongoing phase III trial – called ANNOUNCE – that is due to generate results in early 2019.
For Lilly, Lartruvo extends a growing oncology franchise that is facing generic competition for big-selling Alimta (pemetrexed), which saw sales slide 11% to $2.5bn last year after losing patent protection in the EU and Japan.
Lilly still has patent protection for the blockbuster in the US until 2022, and in the meantime needs Lartruvo and other recent launches such as Cyramza (ramucirumab) and Portrazza (necitumumab) to step into the breach.