Spanish group PharmaMar’s novel cancer drug Yondelis has now been launched in the UK, bringing new hope to the 1,350 patients diagnosed with soft tissue sarcomas each year.

Yondelis (trabectedin), a marine-based anticancer drug derived from the sea-squirt, is the first new treatment approved for patients with advanced soft tissue sarcoma in over two decades, the group claims, and has been cleared for use as a second-line therapy when standard treatments have failed.

“This is good news for soft tissue sarcoma patients in the UK since we have few effective drugs for the 50%, or so, of patients who develop distant metastases (tumour spread),” commented Professor Ian Judson, Professor of Cancer Pharmacology at the Royal Marsden Hospital in London. “These patients require chemotherapy, which can be highly toxic and is often ineffective, [but] trabectedin is a reasonably well-tolerated therapeutic option which can benefit patients after failure of current standard first-line treatments,” he explained.

There are more than 50 different types of soft tissue sarcomas, a group of diverse and tumours that occur in soft tissues such as fat, muscles, nerves and lymph vessels. The prognosis for patients with metastases is particularly bleak, as most die within eight-twelve months and the five-year survival rate just 10%-15%, the firm said.

Treatment options are fairly limited, with systematic chemotherapy the gold standard when complete reaction of metastases is not possible, but response rates are just 10%-25%, underscoring the urgent need for effective alternatives.

Tumour control
Yondelis finally received its European green light in September 2007, after a series of delays, on the back of clinical studies showing that the drug was able to control tumour growth in around 50% of patients, including those whose sarcoma had progressed in spite of chemotherapy. Furthermore, the agent seems to be relatively well-tolerated, and the most common side effects were “non-cumulative, reversible and manageable” in most cases, the group said.

PharmaMar is certainly hopeful in Yondelis’ potential as an anticancer agent. A pivotal Phase III trial is currently testing the drug in ovarian cancer, and Phase II studies are underway in prostate and breast cancers. If approved in all these indications, analysts think the agent could generate peak sales of more than 1 billion euros a year.