Zaltrap launched in UK
pharmafile | March 4, 2013 | News story | Sales and Marketing | Sanofi, Zaltrap
Sanofi and Regeneron Pharmaceuticals’ bowel cancer drug Zaltrap has been launched in the UK today.
Zaltrap (aflibercept) will be used in combination with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in adults with metastatic colorectal cancer (mCRC) whose disease is resistant to, or has progressed after, an oxaliplatin-containing regimen.
It is the first treatment to have shown improved survival in this patient group and NICE is to review Zaltrap later this year: approved NHS options at present are oxaliplatin-based treatment, with Folfiri the next recommended regime.
Zaltrap, which is predicted to make peak annual sales of up to $400 million, has been approved in the US as well as Europe after performing well in the Phase III VELOUR trial, improving median survival from 12.06 months to 13.5 months when added to Folfiri.
Progression-free survival (PFS) also improved, from 4.67 months to 6.9 months, while the overall response rate in the Zaltrap plus Folfiri arm was 19.8% versus 11.1% for Folfiri alone.
Zaltrap’s novel mode of action binds to angiogenic factors VEGF-A as well as uniquely targeting VEGF-B and placental growth factor (PIGF).
It works by preventing the formation of new blood vessels within and around a tumour, thus stopping or slowing the spread of cancer.
Colorectal is the most common cancer in both men and women in Europe and the second leading cause of cancer mortality: in 2008, there were 436,000 new cases diagnosed and 212,000 deaths.
“The availability of Zaltrap fulfills an important unmet need,” said Dr Antonio Saha, colorectal lead & oncology medical advisor for Sanofi UK & Ireland.
But it faces stiff competition in mCRC from more established treatments: Roche’s Avastin, Bayer’s Stivarga, Bristol-Myers Squibb/Merck Serono’s Erbitux and Amgen’s Vectibix.
And as well as being later to market, Zaltrap has failed in studies for prostate, lung and pancreatic cancer, and colorectal cancer, making further indications less likely.
However, eyes will now turn to NICE’s decision-making process.
“MCRC is a difficult disease to treat,” said Dr Rob Glynne-Jones, Macmillan lead clinician in gastro-intestinal cancer. “Zaltrap is a novel agent which has produced results that extend life in the later stages of colorectal cancer and has the potential to significantly impact mCRC survival rates in the future.”
Mark Flannagan, chief executive of the charity Beating Bowel Cancer called the UK launch “excellent news” for patients. “We await the results of the NICE Single Technology Appraisal with interest,” he added.
In trials, a consistent overall survival and PFS improvement was also seen with Zaltrap in pre-specified subgroups including both prior Avastin-treated (approximately 30%) and Avastin-naïve patients.
Adam Hill
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