Velcade gains mantle cell claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Millenium Pharmaceutical's oncologic Velcade (bortezomib) is approved for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, the company announces Dec. 8. MCL is a relatively uncommon and aggressive subtype of non-Hodgkins lymphoma for which there is no cure in the relapsed or refractory setting. The condition has a U.S. prevalence of 10,000 patients. The approval was based on the company's Phase II PINNACLE trial, a single-arm, open-label study that enrolled 155 patients and showed an overall response rate of 31 percent. Velcade is currently the market leader in multiple myeloma for patients who have received one prior therapy. The drug is being codeveloped with Johnson & Johnson...
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.