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Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively
DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…
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The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry Â
The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma Â
PharmaShots has compiled a list of 4 drugs that have been…
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J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure
Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…
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CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…
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MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8)
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…
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MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…
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The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review
Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America
At 59mos. mFU, trial…
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Cell and gene therapies provide a promising opportunity to enhance care for unmet healthcare needs. Biopharma companies are actively exploring these therapies across multiple indications to address healthcare gaps in rare and chronic diseases
In 2023, the cell and gene therapy market was valued at $18.2B and is projected to grow to $117.46B by…
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As a fund-raising initiative, the International Myeloma Foundation began a 3-day, 2-night cycling expedition from Aug 29thto Sep 3rdÂ
The initiative supports patient education, advocacy, and next-gen research to advance a cure for multiple myelomaÂ
Today, at PharmaShots we have Yelak Biru, President and CEO of the International Myeloma Foundation, shedding light on this…
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Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM)Â
Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myelomaÂ
In late 2022,…

