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Lilly scores FDA okay for Cyramza in liver cancer

Approved as second line treatment after Bayer’s Nexavar

Eli Lilly

Eli Lilly has added a fifth indication for its cancer drug Cyramza, getting an FDA approval for hepatocellular carcinoma (HCC) that expresses high levels of the biomarker alpha-fetoprotein (AFP).

It also received another boost from the US regulator after it removed a boxed warning from its label citing a risk of haemorrhage, gastrointestinal perforation and impaired wound healing with the drug.

HCC is the most common form of liver cancer, and around 40% of patients with advanced tumours express high levels of AFP. Their tumours tend to be more aggressive disease and patients have a poorer prognosis than those with low AFP expression.

The FDA approval is for Cyramza (ramucirumab) – a VEGF receptor 2 antagonist – as a second-line treatment after Bayer’s multikinase inhibitor Nexavar (sorafenib), often used as a first-line targeted therapy in HCC.

Since it first reached the market in 2014, Cyramza has been approved to treat oesophageal cancer, gastric cancer after chemotherapy, non-small cell lung cancer (NSCLC) and colorectal cancer, and has been a steady earner for Lilly.

Last year sales rose 8% to around $820m making it Lilly’s second-largest cancer drug after $2bn lung cancer blockbuster Alimta (pemetrexed), but it has come under pressure as a result of a switch to immuno-oncology drugs in some indications like lung cancer and pricing pressures.

HCC is a big new indication for Cyramza, as liver cancer is the fourth-leading cause of cancer-related death worldwide with an incidence that continues to rise on the back of increased numbers of liver disease patients.

The diagnostic test for AFP has been available for decades and is a simple blood test, so there should be no impediment to a swift uptake of Cyramza in second-line HCC, where there are relatively few treatment options. AFP has been used as a prognostic factor for HCC for many years.

The approval is based on the results from the REACH-2 study, which Lilly says is the first positive phase 3 HCC trial in a biomarker-selected patient population. Data from the trial were published in The Lancet Oncology earlier this year and showed an improvement of 3.1 months in median overall survival compared to placebo (8.1 versus 5.0 months).

Lilly has also filed for approval of Cyramza in AFP-high HCC in the EU and Japan.

It’s also planning to add further indications to the drug’s uses, and recently reported positive progression-free survival (PFS) results in the RELAY trial in first-line EGFR-positive NSCLC, which could be the drug’s sixth indication with filings due midyear.

Article by
Phil Taylor

14th May 2019

From: Regulatory

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