J&J Gets FDA OK in Myeloma
The FDA approved the combination of TECVAYLI (teclistamab‑cqyv) with DARZALEX FASPRO (daratumumab + hyaluronidase) for adults with relapsed/refractory multiple myeloma, strengthening Johnson & Johnson’s oncology portfolio and cross‑sell potential with device segments, reported. Market moves followed — M Holdings Securities initiated a new J&J position, underscoring investor confidence in its multi‑segment strategy.
The [FDA approved]fda.gov the teclistamab–daratumumab hyaluronidase combination on March 5, 2026, and the decision also converted teclistamab’s 2022 accelerated monotherapy approval into a full traditional approval. fda.gov The Phase 3 MajesTEC‑3 [trial randomized]fda.gov 587 patients and reported a progression‑free survival hazard ratio of 0.17 (p<0.0001) with the combo versus investigator‑choice control, plus higher complete response rates (≈81.8% vs 32.1%). fda.gov Analyst forecasts peg the multiple myeloma market in the tens of billions—one estimate targeted ~$33 billion by 2030—while business‑intelligence coverage predicts J&J will be the dominant player by 2030, signaling sizable revenue upside for the approved regimen. fiercepharma.com Institutional flows followed the news: M Holdings [Securities reported]marketbeat.com a new stake of 15,946 J&J shares (≈$2.96M) in its most recent 13F filing, and the FDA label includes a boxed warning for cytokine release syndrome and REMS restrictions for Tecvayli. marketbeat.com
