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Celgene Looks To Longer Revlimid Duration In MM To Expand Revenue

 
• By Stacy Lawrence

At ASH, Celgene detailed the results of its MM-020 study for continuous use of Revlimid in newly diagnosed multiple myeloma patients. That’s just one of several treatment strategies that could significantly increase patient time on the drug – and Revlimid revenues.

Celgene Corp. stuck the landing at this year’s American Society of Hematology conference. It presented positive Phase III data for a Revlimid/dexamethasone (Rev/dex) combination to treat newly diagnosed multiple myeloma patients with continuous therapy. Based on this and other data, it rolled out a grand vision of Revlimid (lenalidomide) as key to almost every emerging aspect of the MM market from pre-symptomatic MM to continuous treatment to maintenance usage.

The biotech hopes to use data from MM-020 and from another study, MM-015, to garner a frontline Revlimid approval in...

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.