Janssen Gets Positive CHMP Opinion for Tecvayli to Treat Blood Cancer
22 Julho 2022 - 08:58AM
Dow Jones News
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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