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Janssen Exec On Speeding Earlier Myeloma Interventions To Market With Key Biomarker

 
• By Eleanor Malone

Having scored a commercial hit with Darzalex in myeloma, Janssen is looking to speed label expansions to the drug to enable it to intercept earlier in the disease. Janssen R&D executive Craig Tendler explained the importance of addressing smoldering myeloma and of recognizing minimal residual disease as a valid surrogate marker in trials.

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Janssen hopes regulators will help speed its plow with new myeloma surrogate endpoint

Since winning FDA approval in fourth-line use to treat multiple myeloma in November 2015, Darzalex (daratumumab) has won approval in the EU and elsewhere, and seen a series of label expansions establishing it as an important single-agent therapy as well as in combination with other treatments. In 2017, worldwide sales totalled $1.24bn.

Janssen Biotech Inc., which licensed the anti-CD38 antibody from Genmab AS of Denmark in 2012, continues to gather evidence aimed at expanding the drug's use still further. In an exclusive interview with Pink Sheet in advance of the American Society of Oncology Meeting in Chicago, Dr

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More from Clinical Trials

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from R&D

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.