By Chris Wack

 

Johnson & Johnson's Janssen Pharmaceutical Cos. said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended conditional marketing authorization for Tecvayli (teclistamab) to treat adults with relapsed and refractory multiple myeloma.

Conditional marketing authorization is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.

In December, the EMA granted accelerated assessment for teclistamab, which reduced the timeframe for the CHMP to review the marketing authorization application.

This CHMP recommendation is based on positive results from a multicohort, open-label, Phase 1/2 study evaluating the safety and efficacy of teclistamab in adults.

Multiple myeloma is an incurable blood cancer. In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,500 patients died, Janssen said.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 22, 2022 07:43 ET (11:43 GMT)

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