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J&J gets green light for front-line Velcade in EU

World News | August 09, 2013


PharmaTimes reporter

J&J gets green light for front-line Velcade in EU

Johnson & Johnson's multiple myeloma treatment Velcade has been cleared as a first-line therapy in the EU, boosting the number of patients eligible for treatment with the drug.

The European Commission gave the go-ahead for Velcade (bortezomib) as induction therapy in combination with dexamethasone and thalidomide in previously-untreated multiple myeloma patients who are eligible for high-dose chemotherapy and a stem cell transplant.

Until now Velcade could only be used in advanced disease and in patients who were ineligible for stem cell transplantation, but J&J subsidiary Janssen-Cilag said earlier use could help improve response rates.

A meta-analysis that compared Velcade-based regimens to non-Velcade-therapy as induction therapy prior to stem cell transplantation found that median progression-free survival (PFS) was significantly higher with J&J's drug, at 36 months versus 29 months.

Velcade has also been approved by the EC as a retreatment in relapsed myeloma patients (in combination with thalidomide and dexamethasone) who have previously responded well to the drug.

"The approval of Velcade as part of induction treatment in myeloma is very good news," said Eric Low, chief executive of patient group Myeloma UK.

"Achieving the best possible response in this setting correlates with better survival outcomes and improved quality of life for patients," he added.

Velcade remains one of J&J's top products, bringing the company $732 million in revenues during the first half of 2013, and is forecast to top $4 billion a year at peak. J&J shares profits on the drug with co-developer Millennium Pharmaceuticals, which is part of Takeda.

Approval as induction therapy will help the product cement its position at the top of the multiple myeloma, ahead of Celgene's Revlimid (lenalidomide)and Thalomid (thalidomide).

Meanwhile Velcade also stands to benefit from the recent approvals of Celgene's Pomalyst (pomalidomide) and Onyx Pharma's Kyprolis (carfilzomib), which will be used in combination with Takeda and J&J's drug.
 

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