Lilly to market stomach cancer drug in Europe
pharmafile | December 22, 2014 | News story | Sales and Marketing | Eli Lilly, Europe, FDA, US, cyramza, ramucirumab, stomach cancer
Eli Lilly has been granted permission by the European Commission to market Cyramza in Europe.
Lilly’s Cyramza (ramucirumab) is the first licensed drug specifically indicated for adults with recurrent advanced stomach cancer, or gastro-oesophageal junction adenocarcinoma, who have had chemotherapy (with fluoropyrimidine and platinum).
Cyramza works by binding to a receptor that blocks a key pathway that feeds the growth of tumours. It is approved in combination with paclitaxel chemotherapy, and as a single agent in patients who cannot have treatment with paclitaxel.
The drug’s approval is based on two Phase III studies, which found it extended overall survival and delayed disease progression compared with chemotherapy alone.
It was granted orphan drug designation by the European Commission for treatment of stomach cancer in the EU, and comes just days after Lilly gained US FDA approval as a treatment for lung cancer.
There are several studies planned or already underway to investigate Cyramza for other cancers. Lilly expects to make marketing applications for Cyramza as metastatic non-small cell lung cancer and colorectal cancer treatments in the EU in 2015.
Professor David Ferry, global senior medical director, Lilly Oncology says: “Unfortunately, most patients with gastric cancer face a poor prognosis. Around 80% are first diagnosed once their cancer has spread and become difficult to treat. Despite research efforts, there have been few advances in the last 30 years and inoperable gastric cancer remains a devastating disease. Cyramza provides a welcome new treatment option for these patients.”
Dr Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, adds: “Today marks an important milestone for patients with this difficult-to-treat disease. Cyramza’s development is testament to our commitment to support people living with cancer and those who care for them.”
Meanwhile Astra Zeneca has received more good news after its cancer drug Lynparza (olaparib) gained EMA approval as an ovarian treatment. The drug has also been conditionally approved by the FDA as the first monotherapy for patients with BRCA-mutated advanced ovarian cancer, but only for those who have received three or more prior lines of chemotherapy.
Lynparza has been pushed through the FDA’s accelerated approval programme after promising early-stage clinical trial results. AstraZeneca will have to supply convincing results from ongoing Phase III trials to gain full FDA approval.
Lilian Anekwe
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