J&J's Janssen Seeks FDA OK of Teclistamab in Multiple Myeloma
30 December 2021 - 12:54AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's Janssen Pharmaceutical Cos. unit on
Wednesday said it filed for U.S. Food and Drug Administration
approval of teclistamab for the treatment of patients with relapsed
or refractory multiple myeloma.
Janssen said the application is supported by data from an
open-label, multicenter clinical trial evaluating the safety and
efficacy of teclistamab in adults with the incurable blood
cancer.
The company earlier this month reported new data from the study
that showed continued deep and durable responses of teclistamab in
heavily pretreated patients.
Janssen is currently evaluating teclistamab, an off-the-shelf
T-cell investigational redirecting bispecific antibody, in several
monotherapy and combination studies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 29, 2021 08:39 ET (13:39 GMT)
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