J&J filed for approval of Teclistamab for patients with refractory multiple myeloma

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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.

J&J’s Janssen Seeks FDA OK of Teclistamab in Multiple Myeloma >JNJ – MarketWatch