Category: daratumumab
Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with RRMM who have received at least one prior treatment regimen including lenalidomide & a proteasome inhibitor The study met its 1EPs of PFS & showed 37% reduction in risk of […]
Shots: The P-III MAIA study assessing Darzalex + lenalidomide & dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with MM ineligible for high-dose CT & ASCT MAIA longer-term follow-up analysis showed i.e @5yrs., OS rate (66% vs 53%), PFS rate (53% vs 29%), ORR (93% vs 82%) & median time to next […]
Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT) Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in […]
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar […]
Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd) in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies The approval of q2w dosing regimen is based on P-III CANDOR study assessing […]
Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile […]