Johnson & Johnson
Medical Device R&D and Manufacturer
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2025Year5Month21Breaking News: Johnson & Johnson Announces Major Development – Its DrugDarzalex Faspro(Daratumumab Subcutaneous Formulation) ObtainedFDATumor Drug Advisory Committee (ODAC) Key Support.The Committee with6Votes in favor,2The vote of opposition resulted in the approval of the drug for the treatment of high-risk smoldering multiple myeloma (SMM) Benefits-Risk Ratio.This means,DarzalexExpected to become the first approved forSMMThe treatment drug brings hope to patients with this early-stage cancer, for which there is currently no targeted therapy.
As multiple myeloma (MM) The asymptomatic prodromal stage,SMMPatients typically have no obvious symptoms but are at a higher risk of progressing to active myeloma. Currently, there are no specific treatments available globally.SMMThe approved therapy, patients mainly receive watchful waiting. If thisFDAAdopt the advisory group's recommendations,DarzalexWill fill this treatment gap.
The core basis for this recognition is Johnson & Johnson'sⅢPeriodAquilaThe trial, which comparedDarzalex FasproCompared with simple observation in high-riskSMMEfficacy in patients, the results showedDarzalexThe group reduced the risk of disease progression.51%, and early trends suggest it may extend the overall survival period of patients.
Compared with the active surveillance group:
Significantly Reduce the Risk of Disease Progression:Darzalex FasproTreatment will be high-riskSMMThe risk of patients progressing to active multiple myeloma or death was reduced.51%（HR = 0.49; 95% CI, 0.36-0.67; P < 0.001）。
Improving Progression-Free Survival Rate: Median Follow-Up Time Approximately65months (more than five years) of data show,Darzalex FasproThe five-year progression-free survival of the treatment group (PFS) Rate is63.1% , while the active surveillance group was only40.8% 。
Improving Overall Survival Trend: Five-Year Overall Survival Rate (OS) aspect,Darzalex FasproTreatment Group93% , The active surveillance group is86.9% . The treatment group also had a relatively lower risk of death (treatment group7.7% vs. Control Group13.3%）。
Higher Remission Rate:Darzalex FasproTotal response rate of the treatment group (ORR) has reached63.4% , while the active surveillance group had almost no relief (control groupORRApproximately1%-2%), where8.8% of patients achieved complete remission (CR) or better relief, while the control group was0%。
However,FDAThree Major Questions Raised About the Experimental Data:First, according to the current high-risk standards, only41%The subjects met the requirements, but the observation group50%Patient3Progression to active myeloma within the year suggests that the enrolled population remains at high risk; secondly, it is believed that a simple delay in progression has insufficient clinical value and needs to be combined with progression-free survival (PFS) in second-line treatment.PFS2) and overall survival (OS) data, while subgroup analysis showed limited relevant benefits; thirdly, there is concern that early use may affect future treatment sensitivity, and the trial lacked patients receiving treatment after progression.DarzalexAnalysis of Treatment Efficacy.
In terms of safety,DarzalexThe incidence of treatment-related adverse events was higher in the group, although Johnson & Johnson stated that the quality of life of patients in the two groups was similar, butFDAQuestions Remain Over Assessment Method. Some experts believe that the anticipated significant benefits for high-risk patient groups may outweigh the risks, but the committee still calls for strict limitations on the applicable population upon approval and continued follow-up trials to monitor efficacy and safety over the long term.
This approval controversy reflects common challenges in the field of early cancer treatment, such as precise patient selection, endpoint design rationality, and the balance of treatment risks.NCIExpertRavi MadanReflection:“Can be treated”Is Equal To“The Treatment”？This issue may impact the direction of R&D in the oncology field.
CurrentlyFDAAlthough it is not mandatory to follow the advisory panel's recommendations, the historical adoption rate exceeds90%. IfDarzalexFinally approved, will rewriteSMMTreatment landscape, providing a reference for the early application of similar drugs. For patients, this may be from“Passive Observation”Turn to“Active Intervention”a turning point; for the industry, it is a critical step in the exploration of early cancer treatment. In the future, as long-term trial data is disclosed, regarding“Necessity of Early Treatment”The debate is expected to gradually become clear.
Reference:fierce biotech