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Multiple Myeloma Market Snapshot: New Combos Offer Greater Longevity, But Payers May Push Back

 
• By Stacy Lawrence

Mortality for this deadly disease has been pushed back due to therapeutic innovations. But to make further strides, new mechanisms of action and combination approaches will need to come further into play. These advances and the eventual genericization of Velcade are likely to make the regulatory and payer environment increasingly complicated.

In the absence of a cure, postponing the progression and mortality of cancer indefinitely is the next most desirable outcome. That’s the hope in multiple myeloma (MM) – that combinations of treatments involving an ever-expanding roster of drugs with various mechanisms of action will mean these typically elderly patients will have causes of death unrelated to the disease.

The model for this, of course, is another oft-cited hematological cancer, chronic myelogenous leukemia (CML). While tyrosine kinase inhibitors (TKIs)...

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More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from North America