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Home Industry News Janssen-Cilag submits marketing application for Velcade

Janssen-Cilag submits marketing application for Velcade

28th December 2007

Janssen-Cilag has submitted a Marketing Authorisation Application to the European Medicines Evaluations Agency for the use of Velcade (Bortezornib) in patients with previously untreated multiple myeloma (MM).

In addition, Janssen-Cilag’s co-development partner Millennium Pharmaceuticals has submitted a supplemental New Drug Application to the US Food and Drug Administration in an attempt to gain marketing approval for the Velcade indication in America.

Application submissions are based on data from the company’s phase III Vista trials which compared melphalan and prednisone treatment with just prednisone treatment for previously untreated patients.

The study found that patients on a Velcade-based regimen experienced a 35 per cent complete response rate as defined by complete disappearance of M protein.

It was also demonstrated that the responses were durable, with the median duration of response for complete responders at 24 months.
Study results were also presented at the American Society of Haematology 49th Annual Meeting in Atlanta , Georgia earlier this year.
MM is the second most common blood cancer with 85,700 cases of the disease globally in 2002.

Earlier this month, Centocor and Janssen-Cilag submitted regulatory applications requesting the approval of ustekinumab (CNT0 1275) in the US and Europe for the treatment of patients with moderate to severe plaque psoriasis.

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