Regulatory milestones approvals, filings & regulatory actions · 5 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
FiledAH amyloidosis1 milestone
Filed
US (FDA)
DARZALEX FASPRO
AH amyloidosis
2020-09-10
“Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis” jnj.com ↗
“has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™” halozyme.com ↗
Filedplasma cell myeloma1 milestone
Filed
US (FDA)
DARZALEX FASPRO®
plasma cell myeloma
2024-01-30
“announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for...” jnj.com ↗
“regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma.” jnj.com ↗
“This approval follows Janssen's regulatory submission to the FDA in February 2021.” halozyme.com ↗
Filedprimary plasmacytoma of the bone1 milestone
Filed
US (FDA)
DARZALEX FASPRO
primary plasmacytoma of the bone
2024-09-30
“submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEXFASPRO®” jnj.com ↗
“Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO-based quadruplet regimen” jnj.com ↗
Filedrelapsed/refractory diffuse large B-cell lymphoma2 milestones
Filed
EU (EMA)
DARZALEX
relapsed/refractory diffuse large B-cell lymphoma
2020-11-12
“Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™” jnj.com ↗
Filed
US (FDA)
DARZALEX FASPRO
relapsed/refractory diffuse large B-cell lymphoma
2020-11-12
“Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™” jnj.com ↗
In the MajesTEC-3 study, TECVAYLI®plus DARZALEXFASPRO®significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years.
Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.
The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings.
Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX®subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).
Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).
MajesTEC-3 is the first Phase 3 study to show that the combination of TECVAYLI and DARZALEXFASPROoffers better PFS and OS than current standards of care.
The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma (MM), potentially altering the course of disease and treatment.
Johnson & Johnson (NYSE: JNJ) today announced data highlighting that DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.
RIO DE JANEIRO (September 27, 2024)– Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY®(talquetamab-tgvs) with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination.
DARZALEXFASPRO®plus lenalidomide maintenance therapy also demonstrated a potential benefit in progression-free survival (PFS) with no new safety concerns.
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for DARZALEXFASPRO®
The quadruplet regimen also significantly increased the depth of response compared to treatment with VRd alone, with higher rates of CR or better, stringent complete response (sCR), and MRD negativity.
DARZALEX FASPRO®-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimen
Additional long-term data from the TRiMM-2 study in patients receiving talquetamab and DARZALEX FASPRO® combination biweekly regimen showed an overall response rate of more than 80 percent
At a median follow-up of 8.6 months (range, 0.3-19.6), 76.5 percent (39/51) of response-evaluable patients enrolled in the study achieved a response, including 36 patients (70.6 percent) who achieved a very good partial response (VGPR) or better.
suggest a manageable safety profile and preliminary efficacy in patients with relapsed or refractory disease who had received a minimum of three prior lines of treatment.
Results suggest that the combination is tolerable in patients with relapsed or refractory multiple myeloma who had received a median of six prior lines of therapy (range 2-18)
The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma.
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEXFASPRO®in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003).
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003).
Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis
The applications seek approval of the combination of DARZALEX FASPRO™/DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis
The data demonstrated subcutaneous daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate (CR), (53 percent vs. 18 percent [P<0.0001]), compared to CyBorD.
Every value below carries the sentence it was read from.
1 source stands behind the page.
Field
Value
Cited text
Known as
daratumumab and hyaluronidase-fihj
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT06398457 ↗
Known as
Darzalex Faspro
“This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells...” NCT06398457 ↗
Action
Deplete
“an anti- 38 (cluster of differentiation 38) antibody that kills plasma cells” NCT06398457 ↗