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Extra stomach cancer indication for Cyramza in US

FDA backs Lilly drug in combination with paclitaxel chemotherapy
lilly cyramza ramucirumab

Lilly's oncology drug Cyramza was yesterday approved in a second stomach cancer indication in the US.

The FDA gave the green light for the drug in combination with paclitaxel chemotherapy to treat people with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma whose disease has progressed after treatment with fluoropyrimidine or platinum-containing chemotherapy.

The approval expands the use of Cyramza in the US where it was approved in April as a single agent to treat patients that fit this criteria.

Cyramza is the only FDA-approved second-line treatment option for patients with this specific form of stomach cancer. The drug is also classed as an orphan product due to rarity of the condition, giving Lilly certain regulatory perks.

Dr Richard Gaynor, senior VP, product development and medical affairs for Lilly Oncology, said: "This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease."

Lilly has high hopes for Cyramza, which some analysts expect to be a $1bn-plus product depending on the number of indications it gains approval in.

The drug has shown potential in other cancers, including metastatic colorectal cancer, with phase III results posted in September and regulatory submissions expected early next year.

Lilly has also submitted Cyramza to the FDA as a treatment for second-line non-small cell lung cancer.

Outside the US Cyramza has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in stomach cancer, while Lilly has also submitted the drug in a similar indication in Japan where it is designated a priority review product.

The drug has not shown promise in all its proposed indications, however. In June this year Lilly posted disappointing data regarding its ability to improve survival in patients with hepatocellular carcinoma, a type of liver cancer.

Cyramza had previously failed in a phase III trial investigating its use in breast cancer.

6th November 2014

From: Sales



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