Drug file · From the Watchtower
Talquetamab: the briefings and the record
Every Prognyx briefing on talquetamab, newest first, and the dated events drawn from the sources those briefings cite. Rebuilt with each new briefing.
- Also known as
- TALVEY, GPRC5D×CD3 bispecific
- Target, as briefed
- GPRC5D x CD3 bispecific antibody
- Companies named
- Janssen-Cilag International N.V., Johnson & Johnson
- Prognyx coverage
- 2 briefings, 17 October 2026 to 11 November 2026
Prognyx briefings on talquetamab
- relapsed/refractory multiple myeloma (second-line and beyond)J&J's TECVAYLI-TALVEY Phase 3 cuts myeloma progression risk as early as second line
The company's ASH 2026 release reports Phase 3 data for the TECVAYLI-TALVEY bispecific pair reducing progression risk in relapsed myeloma as early as second line, plus first results for ramantamig, a trispecific built on DARZALEX.
- multiple myelomaCHMP backs a label change for Janssen's myeloma bispecific Talvey
On 15 October 2026 the CHMP recommended a change to Talvey's EU marketing authorisation; the EMA record does not state what the change covers.
Sourced timeline
Readouts, regulatory actions, filings, trial starts and deals that the Prognyx engine extracted from the documents cited in these briefings, newest first. Each links to its source and to the briefing that cited it. Press coverage is left out, and so is any event dated on its own briefing's day: the briefing above is the record for that day. A month without a day is a date the source gave only to the month.
- Regulatory actionCHMP positive opinion for Talvey marketing-authorisation label changeEMA/CHMP post-authorisation procedure · cited in CHMP backs a label change for Janssen's myeloma bispecific Talv…
- SuspensionNCT06572605 (EBRT + talquetamab) suspended, pending amendmentClinicalTrials.gov · cited in CHMP backs a label change for Janssen's myeloma bispecific Talv…
- ReadoutMonumenTAL-1 China cohort safety profile publishedPeer-reviewed journal (Hematology) · cited in CHMP backs a label change for Janssen's myeloma bispecific Talv…
Registered trials on file
ClinicalTrials.gov records that the cited sources tie to talquetamab, each opening on the registry.
- NCT07657312 Infliximab for CRS prophylaxis during teclistamab or talquetamab (Phase 2)
- NCT06572605 EBRT + talquetamab in extramedullary multiple myeloma
- NCT06500884 GPRC5D-related oral-event prevention study
- NCT06208150 NCT06208150 (talquetamab combos vs EPd/PVd, Ph3)
- NCT05757973 Pre-Approval Access Program for talquetamab monotherapy
- NCT05503550 Pre-Approval Access Single Patient Request for talquetamab
- NCT05050097 Talquetamab combination regimens (Phase 1)
- NCT04634552 Phase 2 talquetamab study in relapsed/refractory multiple myeloma
- NCT03399799 Phase 1 talquetamab dose-escalation study
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Prognyx briefings are built from public information and reflect Prognyx's analysis. They are not investment advice and do not promote any product or off-label use. Event titles are written by the Prognyx engine from the linked source; the source is the record.