Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Velcade Gets Priority Review for Mantle Cell Lymphoma | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

Velcade Gets Priority Review for Mantle Cell Lymphoma

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Millennium’s sNDA for Velecade for the treatment of relapsed mantle cell lymphoma (MCL) was granted Priority Review designation by the FDA. MCL is an aggressive, incurable subtype of non-Hodgkin’s lymphoma (NHL) for which there is no current standard of care. Priority Review is granted to compounds that address an unmet medical need and would be a significant improvement in treatment compared to existing therapies.

The sNDA submission was based on Phase II data from the PINNACLE study, which showed a 33% overall response rate and an 8% complete response rate. Significantly, the median duration of response was 9.2 months, and 13.5 months in patients who achieved a complete response. These results are similar to those of four investigator initiated Phase II trials where overall response rates of 30 to 40% with single-agent Velcade were established.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters