What do oncologists think of the AQUILA trial (DARZALEX®)?
AQUILA — High-risk smoldering multiple myeloma (subcutaneous daratumumab monotherapy vs active monitoring)
FDA APPROVED · Nov 2025 · first-in-classDARZALEX FASPRO® (subcutaneous daratumumab) is FDA-approved (November 6, 2025) for adults with high-risk smoldering multiple myeloma — the first and only therapy approved in this setting, based on AQUILA.
Physician voices — verbatim
Full physician voice list (60)
What do oncologists think of the PERSEUS trial (DARZALEX®)?
PERSEUS — Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VRd induction/consolidation, then daratumumab–lenalidomide maintenance)
FDA APPROVED · Jul 2024DARZALEX FASPRO® with VRd (bortezomib, lenalidomide, dexamethasone) is FDA-approved (July 30, 2024) as induction and consolidation for transplant-eligible newly diagnosed multiple myeloma, based on PERSEUS.
Physician voices — verbatim
Full physician voice list (26)
What do oncologists think of the CASSIOPEIA trial (DARZALEX®)?
CASSIOPEIA — Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VTd induction and consolidation)
FDA APPROVED · Sep 2019DARZALEX® with VTd (bortezomib, thalidomide, dexamethasone) is FDA-approved (September 26, 2019) as induction and consolidation for transplant-eligible newly diagnosed multiple myeloma, based on CASSIOPEIA.
Physician voices — verbatim
Full physician voice list (29)
What do oncologists think of the GRIFFIN trial (DARZALEX®)?
GRIFFIN — Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VRd quadruplet; Phase 2 signal-generating study)
REGIMEN FDA-APPROVED (via PERSEUS) · Jul 2024The daratumumab + VRd quadruplet GRIFFIN evaluated (Phase 2) is now FDA-approved for transplant-eligible newly diagnosed multiple myeloma — carried by the confirmatory Phase 3 PERSEUS trial (approved July 30, 2024). GRIFFIN itself was signal-generating, not registrational.
Physician voices — verbatim
Full physician voice list (5)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
DARZALEX® — FDA status
FDA APPROVEDDARZALEX® (daratumumab, intravenous) and DARZALEX FASPRO® (subcutaneous daratumumab plus hyaluronidase) are FDA-approved for multiple myeloma across several settings — from high-risk smoldering disease to newly diagnosed transplant-eligible and transplant-ineligible myeloma and the relapsed/refractory setting. Marketed by Johnson & Johnson (Janssen); originated with Genmab. For the full, current list of FDA indications and prescribing information, see darzalex.com or FDA label (DailyMed). KOL Pulse indexes the physician conversation; the label is owned and maintained by the manufacturer.
DARZALEX® sentiment — FAQ
AQUILA
What do oncologists think of the AQUILA trial (DARZALEX®)?
Across 60 verified physician voices in KOL Pulse's index for AQUILA, 34% expressed positive sentiment, 8% were nuanced (praising the result while flagging a caveat), 53% were neutral, and 5% were critical. Positive voices highlight the first therapy shown to delay progression to active multiple myeloma in high-risk smoldering disease, opening a genuinely new treatment setting; nuanced and critical voices flag whether asymptomatic patients should be treated at all — overtreatment, overall-survival and quality-of-life maturity, risk-model patient selection, and the cost and burden of treating a precursor condition.
Where can I find the AQUILA trial data for DARZALEX® (daratumumab)?
AQUILA is registered as NCT03301220 and studied DARZALEX® (daratumumab) in High-risk smoldering multiple myeloma (subcutaneous daratumumab monotherapy vs active monitoring). For the full AQUILA trial data and conference coverage, see the KOL Pulse AQUILA trial profile at kolpulse.com/kol-pulse-trial-profile-aquila.
PERSEUS
What do oncologists think of the PERSEUS trial (DARZALEX®)?
Across 26 verified physician voices in KOL Pulse's index for PERSEUS, 42% expressed positive sentiment, 12% were nuanced (praising the result while flagging a caveat), 46% were neutral, and 0% were critical. Positive voices highlight the progression-free-survival benefit and deep, sustained MRD-negativity from adding daratumumab to VRd — establishing the quadruplet as a new standard for transplant-eligible patients; nuanced and critical voices flag added infection and toxicity risk, the optimal maintenance duration, and how the quadruplet applies to older or frailer patients.
Where can I find the PERSEUS trial data for DARZALEX® (daratumumab)?
PERSEUS is registered as NCT03710603 and studied DARZALEX® (daratumumab) in Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VRd induction/consolidation, then daratumumab–lenalidomide maintenance). For the full PERSEUS trial data and conference coverage, see the KOL Pulse PERSEUS trial profile at kolpulse.com/kol-pulse-trial-profile-perseus.
CASSIOPEIA
What do oncologists think of the CASSIOPEIA trial (DARZALEX®)?
Across 29 verified physician voices in KOL Pulse's index for CASSIOPEIA, 21% expressed positive sentiment, 17% were nuanced (praising the result while flagging a caveat), 55% were neutral, and 7% were critical. Positive voices highlight the improved depth of response and progression-free survival from adding daratumumab to a transplant-eligible induction backbone; nuanced and critical voices flag the thalidomide-based VTd backbone (less used in the US), the maintenance-strategy question, and overall-survival maturity.
Where can I find the CASSIOPEIA trial data for DARZALEX® (daratumumab)?
CASSIOPEIA is registered as NCT02541383 and studied DARZALEX® (daratumumab) in Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VTd induction and consolidation). For the full CASSIOPEIA trial data and conference coverage, see the KOL Pulse CASSIOPEIA trial profile at kolpulse.com/kol-pulse-trial-profile-cassiopeia.
GRIFFIN
What do oncologists think of the GRIFFIN trial (DARZALEX®)?
Across 5 verified physician voices in KOL Pulse's index for GRIFFIN, 40% expressed positive sentiment, 20% were nuanced (praising the result while flagging a caveat), 40% were neutral, and 0% were critical. Positive voices highlight the deep responses and high MRD-negativity that supported adding daratumumab to VRd and motivated the Phase 3 confirmatory program; nuanced and critical voices flag the Phase 2 sample size and the need for the Phase 3 PERSEUS readout before the quadruplet could be considered a standard.
Where can I find the GRIFFIN trial data for DARZALEX® (daratumumab)?
GRIFFIN is registered as NCT02874742 and studied DARZALEX® (daratumumab) in Transplant-eligible newly diagnosed multiple myeloma (daratumumab + VRd quadruplet; Phase 2 signal-generating study). KOL Pulse's GRIFFIN trial profile is coming soon.
Regulatory
Is DARZALEX® (daratumumab) FDA approved?
DARZALEX® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.