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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Both bispecifics have arisen out of J&J’s longstanding alliance with Genmab, which also generated anti-CD38 blockbuster Darzalex (daratumumab). Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – and BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel).

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CHMP backs J&J’s myeloma CAR-T therapy Carvykti

pharmaphorum

The KarMMa trial of Abecma involved a similar patient group – treated with at least three lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody such as J&J’s Darzalex (daratumumab) – with an overall response rate of 72% and 28% complete responses.