Date: 2012-04-11
Type of information: Granting of a Market Authorisation in the EU
Product name: Zaltrap®
Compound: ziv-aflibercept
Therapeutic area: Cancer - Oncology
Action mechanism: fusion protein/VEGF receptor. Zaltrap® (ziv-aflibercept) is an investigational angiogenesis inhibitor with a unique mechanism of action. This fusion protein binds multiple forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. It has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their native receptors.
Company: Sanofi (France) Regeneron Pharmaceuticals (USA)
Disease: metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen
Latest news: * On February 5, 2013, Sanofi and Regeneron Pharmaceuticals have announced that the European Commission has granted marketing authorization in the European Union for Zaltrap® 25mg/ml concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. This decision was based on the efficacy and safety results of the VELOUR Phase 3 trial. Zaltrap® received approval from the FDA in August 2012 after a Priority Review, and marketing authorization applications for ZALTRAP are under review with other regulatory agencies worldwide.
* On November 15, 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Zaltrap®, 25 mg/ml, concentrate for solution for infusion, intended, in combination with irinotecan/ 5-fluorouracil/ folinic acid (FOLFIRI) chemotherapy, for the treatment of adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
The benefits with Zaltrap® are its ability to improve the survival of patients and to delay the progression of disease compared to placebo. The most common side effects are leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache. A pharmacovigilance plan for Zaltrap® will be implemented as part of the marketing authorisation.
The approved indication is: "Zaltrap® in combination with irinotecan/5 fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin containing regimen". It is proposed that Zaltrap® be prescribed by physicians experienced in the use of antineoplastic medicinal products.
* On August 3, 2012, Sanofi and Regeneron Pharmaceuticals have announced that the FDA approved Zaltrap® (ziv-aflibercept) Injection for Intravenous Infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. The drug was approved following a Priority Review by the FDA. Marketing authorization applications for Zaltrap® are also under review by the European Medicines Agency (EMA) and other regulatory agencies worldwide.
* On April 5, 2012, Sanofi and Regeneron Pharmaceuticals announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent Zaltrap® (aflibercept) concentrate for solution for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen. Under Priority Review, the target date for an FDA decision on the BLA is August 4, 2012. The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen .
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-08-03
UE authorization: 2013-02-05
Favourable opinion UE: 2012-11-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
