Regulators on both sides of the Atlantic are recommending that doctors not start any new patients on a cancer drug made by Eli Lilly & Co.

The Food and Drug Administration said Thursday that the drug, Lartruvo (olaratumab), should not be initiated in new patients, and patients already on it should consult with their doctors about whether to keep using it. The recommendation is in light of data from a Phase III trial released Jan. 18 that failed to confirm the benefit shown in an earlier Phase II study that led to the drug’s October 2016 accelerated approval. Lartruvo is used in combination with the chemotherapy drug doxorubicin to treat soft-tissue sarcomas.

The Phase II study – in 133 patients with 25 different subtypes of metastatic STS – showed that Lartruvo and doxorubicin prolonged overall survival and progression-free survival compared with doxorubicin alone. However, the Phase III study results announced last week did not show a similar benefit. Indianapolis-based Lilly said they did not support initiating new patients on the drug, and that it would suspend its promotion.

The FDA announcement follows a similar one made by the European Medicines Agency on Wednesday recommending that no new patients should be started on Lartruvo. The agency estimated that 1,000 patients in the EU are currently being treated with the drug. According to the American Cancer Society, about 13,040 cases of STS will be diagnosed in the US. It is a complex and hard-to-treat disease with numerous subtypes.

As a result of the failed trial, the FDA could require changes to Lartruvo’s label or withdraw its approval entirely, according to the agency’s policies.

The news is a blow to Lilly, which has sought to diversify its portfolio and drug development efforts into cancers, particularly with the acquisition earlier this month, during the J.P. Morgan Healthcare Conference in San Francisco, of Loxo Oncology for $8 billion.

Other drugs approved for STS subtypes include Johnson & Johnson subsidiary Janssen Oncology and PharmaMar’s Yondelis (trabectedin); Eisai’s Halaven (eribulin mesylate); and Novartis’s Votrient (pazopanib).

Photo: US Food and Drug Administration

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