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Janssen’s Multiple Myeloma Drug Among 11 Products To Get EMA Thumbs Up

Labeling Extension In Store For Bavarian Nordic’s Smallpox Vaccine To Include Monkeypox

 
• By Vibha Sharma

The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances. 

Multiple myeloma cells emitting M (Monoclonal) protein in the blood flow - isometric view 3d illustration
Janssen’s Tecvayli Is A Novel Bispecific Antibody To Treat Multiple Myeloma • Source: Alamy

Tecvayli (teclistamab) is on track to winning pan EU-marketing approval, following the European Medicines Agency’s recommendation that the drug, from Janssen Pharmaceutical, be granted a conditional marketing authorization for treating adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.

An off-the-shelf, T-cell redirecting bispecific antibody, Tecvayli is still under review in the US

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More from Approvals

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• By Neena Brizmohun

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New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

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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.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.