This section highlights FDA-related milestones and regulatory updates for drugs developed by Halozyme Therapeutics (HALO).
Over the past two years, Halozyme Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DARZALEX, DARZALEX, and Tecentriq. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DARZALEX (daratumumab) - FDA Regulatory Timeline and Events
DARZALEX (daratumumab) is a drug developed by Halozyme Therapeutics for the following indication: Newly diagnosed systemic light chain (AL) amyloidosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARZALEX (daratumumab)
- Announced Date:
- April 9, 2025
- Indication:
- Newly diagnosed systemic light chain (AL) amyloidosis
Announcement
Halozyme Therapeutics, Inc. announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting.
AI Summary
Halozyme Therapeutics announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission approval for an indication extension of DARZALEX® (daratumumab) administered subcutaneously using ENHANZE® drug delivery technology. This new approval allows daratumumab to be used in a frontline setting for adult patients with newly diagnosed multiple myeloma as part of a combination treatment with bortezomib, lenalidomide, and dexamethasone (VRd).
The updated approval means that patients can now benefit from a subcutaneous injection that avoids lengthy IV infusions, making treatment more convenient and reducing the overall treatment burden. Dr. Helen Torley, CEO of Halozyme, expressed that this reinforces DARZALEX’s role as a cornerstone in multiple myeloma therapy, offering a more patient-friendly option in the frontline treatment of the disease.
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DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone - FDA Regulatory Timeline and Events
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone is a drug developed by Halozyme Therapeutics for the following indication: Multiple Myeloma After First / Subsequent Relapse.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- June 3, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Johnson & Johnson recently announced encouraging data from two studies on its DARZALEX FASPRO®‐based quadruplet regimen for patients newly diagnosed with multiple myeloma (NDMM). The regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, which is seen as a crucial indicator of effective treatment. Additionally, it improved long‐term progression-free survival (PFS) in patients regardless of whether they were eligible for a transplant, suggesting the treatment may offer broad benefits.
The findings were presented as oral presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Specifically, the data from transplant-eligible patients came from an analysis in the Phase 3 PERSEUS study (Abstract #7501), while additional insights from transplant-ineligible patients were shared from a subgroup analysis in the Phase 3 CEPHEUS study (Abstract #7516). These results underline the potential of the regimen as a promising option for NDMM treatment.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- May 20, 2025
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). An application for the approval of DARZALEX FASPRO® for adult patients with HR-SMM was submitted to the FDA in November 2024.
AI Summary
Johnson & Johnson announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for treating adult patients with high-risk smoldering multiple myeloma (HR-SMM). This recommendation was based on positive findings from the Phase 3 AQUILA study, which showed significant improvements in progression-free survival and clinical outcomes. An application for approval was submitted to the FDA in November 2024. If approved, DARZALEX FASPRO® would become the first treatment option aimed at delaying or potentially preventing the progression of HR-SMM to active multiple myeloma, offering a proactive alternative to the current “watch and wait” approach for these patients.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- December 8, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced data from the Phase 3 AQUILA study showing that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delayed progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival compared to the current standard of care of active monitoring.1
AI Summary
Johnson & Johnson announced promising results from the Phase 3 AQUILA study. The study showed that DARZALEX FASPRO® significantly delayed the progression from high-risk smoldering multiple myeloma (SMM) to active multiple myeloma (MM) and improved overall survival compared to the current standard of care, which relies on active monitoring.
These findings suggest that early intervention with DARZALEX FASPRO® may help patients avoid more aggressive treatments later on. Clinicians and regulatory experts are optimistic that this innovative subcutaneous therapy can provide a meaningful benefit by extending the time before the disease advances and by improving survival outcomes. Future studies are expected to further explore its long-term benefits and potential applications in treating multiple myeloma.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- September 30, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.
AI Summary
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for DARZALEX FASPRO® when used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd). This new indication is aimed at treating adult patients with newly diagnosed multiple myeloma (NDMM) who either defer autologous stem cell transplant (ASCT) or cannot undergo the procedure. The application is supported by data from the Phase 3 CEPHEUS study, which showed that 60.9% of patients receiving D-VRd achieved minimal residual disease (MRD) negativity. The study also demonstrated a 43% reduction in the risk of disease progression or death compared to the standard treatment, highlighting the potential of this quadruplet regimen as a treatment option regardless of transplant eligibility.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- September 27, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced today results from the Phase 3 CEPHEUS study demonstrating a significant clinical improvement with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible (TIE) or for whom transplant was not planned as initial therapy (transplant deferred).
AI Summary
Johnson & Johnson announced promising results from the Phase 3 CEPHEUS study, which evaluated DARZALEX FASPRO® (a combination of daratumumab and hyaluronidase-fihj) when paired with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients. The study focused on patients who were either not eligible for transplant or had chosen to delay it. The findings showed a significant clinical improvement in these patients, indicating that the D-VRd regimen can lead to better treatment outcomes. This is encouraging news, as it offers a more effective treatment option for patients who cannot undergo a transplant or prefer to avoid it initially. The results support the potential of DARZALEX FASPRO® to improve quality of life and provide a strong alternative for managing multiple myeloma in this patient group.
Read Announcement- Drug:
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
- Announced Date:
- July 30, 2024
- Indication:
- Multiple Myeloma After First / Subsequent Relapse
Announcement
Johnson & Johnson announced that that the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).1
AI Summary
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplants (ASCT). This combination is used during both the induction and consolidation phases of treatment, offering a new frontline option at the time of diagnosis.
Clinical studies supported this approval, showing that the D-VRd regimen reduced the risk of disease progression or death by 60 percent compared to prior treatments. These findings suggest that the quadruplet therapy can achieve deeper responses and prolong remissions, marking a significant step forward in the treatment of multiple myeloma for transplant-eligible patients.
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Tecentriq Hybreza - FDA Regulatory Timeline and Events
Tecentriq Hybreza is a drug developed by Halozyme Therapeutics for the following indication: For Multiple Types of Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tecentriq Hybreza
- Announced Date:
- September 12, 2024
- Indication:
- For Multiple Types of Cancer
Announcement
Halozyme Therapeutics, Inc. announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology.
AI Summary
Roche has received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™, a new subcutaneous treatment for various cancers. This innovative therapy combines atezolizumab, a monoclonal antibody that helps the immune system fight cancer, with hyaluronidase-tqjs. The latter is part of Halozyme’s proprietary ENHANZE® drug delivery technology.
The new treatment can be injected in about 7 minutes compared to the 30-60 minutes required for the traditional intravenous (IV) infusion of Tecentriq®. Approved for all adult indications where IV Tecentriq® is used, Tecentriq Hybreza™ gives patients and doctors a faster and more convenient option. Halozyme’s CEO, Dr. Helen Torley, expressed excitement about offering added flexibility and improved treatment experience through the use of ENHANZE® technology.
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