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Counting The Cost Of Delay For Revlimid Front-line Myeloma Approval

 
• By Emily Hayes

Fear of second primary cancers foils Celgene’s filing of Revlimid for front-line/maintenance myeloma in Europe. Meanwhile, debate continues about the clinical value and high cost of prolonged treatment, and new options for relapse patients emerge, notably Onyx’s Kyprolis and Celgene’s pomalidomide.

Celgene’s withdrawal of a European submission for blockbuster Revlimid (lenalidomide) in front-line/maintenance multiple myeloma and a delay of the FDA filing in that indication has clear implications for reimbursement in Europe, but may have less of a hit in the U.S. where off-label prescribing is covered by insurance companies.

Currently approved for second-line use in multiple myeloma in the U.S. and Europe, Revlimid sales hit $3.2 billion in 2011,...

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More from Post-Marketing Regulation & Studies

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
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The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

More from Product Reviews

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

New EU Approvals

 
• By Neena Brizmohun

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.