July 2024 New Drug Approvals and Breakthrough Therapy Designations by FDA, NMPA, and CDE
Johnson & Johnson
Medical Device R&D and Manufacturer
FDA & NMPA New Drug Approvals in July 2024 In July, there was 1 FDA-approved drug (new drug/indication). NMPA Approved Drugs (New Drugs/Indications): 3 Included in the CDE's list of potential breakthrough therapies: 2 Statistics as of 2024-7-31,Data source: FDA and NMPA official websites | ||
Approved Drugs/Regimens | Institution | Indications |
Johnson & Johnson's Daratumumab-Hyaluronidase (Megadose) | FDA | FDA Approves Daratumumab-Hyaluronidase Combined with Bortezomib, Lenalidomide, and Dexamethasone for Induction and Consolidation Therapy in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant (ASCT). |
Qilu's Trastuzumab (Antruo) | NMPA | NMPA Approves Trastuzumab for the Treatment of HER2-Positive Early Breast Cancer, Metastatic Breast Cancer, and Metastatic Gastric Cancer. |
Antengene's Selinexor (Xpovio) | NMPA | NMPA Approves Selinexor for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Including DLBCL Transformed from Follicular Lymphoma, Who Have Received at Least 2 Prior Lines of Systemic Therapy. |
Roche's Alectinib (Alecensa) | NMPA | NMPA Approves Alectinib for Anaplastic Lymphoma Kinase (ALK) Positive non-small cell lung cancer patients receive adjuvant treatment after complete tumor resection. |
Xiangxue's TAEST16001 | CDE | TAEST16001 Granted "Breakthrough Therapy Designation" by CDE for the Treatment of Soft Tissue Sarcoma with HLA-A*02:01 Genotype and Positive NY-ESO-1 Tumor Antigen Expression |
Suzhong's Sutent | CDE | Sutent has been included in the "Breakthrough Therapy Designation" by the CDE for the proposed treatment of locally advanced or metastatic non-small cell lung cancer (limited to non-resistant rare types).EGFRMutations, including L861Q, G719X and/or S768I). |
Details of Partial Drug Approvals
FDA Approval Details
FDA Approves Daratumumab-Hyaluronidase Combined with Bortezomib, Lenalidomide, and Dexamethasone for Induction and Consolidation Therapy in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant (ASCT).
On July 30, 2024, the FDA approved daratumumab-hyaluronidase in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment of newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplantation (ASCT).
Approval Basis:This approval is based on PERSEUS (NCT03710603), an open-label, randomized, active-controlled clinical trial. The study evaluated the efficacy in newly diagnosed multiple myeloma patients eligible for ASCT. Enrolled patients were aged ≤70 years. A total of 709 patients were randomly assigned: 355 patients received Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (Darzalex Faspro-VRd), and 354 patients received bortezomib, lenalidomide, and dexamethasone (VRd). The primary efficacy endpoint was progression-free survival (PFS) assessed by an independent review committee according to the International Myeloma Working Group (IMWG) response criteria.
The results showed that compared with the VRd group, PFS was improved in the Janssen-VRd group; the median PFS was not reached in either group. Compared with VRd alone, treatment with Janssen-VRd reduced the risk of disease progression or death by 60% [HR (95% CI): 0.40 (0.29, 0.57); p-value <0.0001].
Adverse Reactions:The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, edema, fever, upper respiratory tract infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.
Recommended Dose:The recommended dose of 兆珂速 is 1800mg/30000 units (1800mg daratumumab and 30000 units hyaluronidase).
NMPA Approval Details
1. On June 28, 2024, NMPA approved Qilu's trastuzumab for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
2. On June 28, 2024, NMPA approved Antengene's Selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL transformed from follicular lymphoma, who have received at least two prior lines of systemic therapy.
3. On June 28, 2024, the NMPA approved Roche's Alectinib for anaplastic lymphoma kinase (ALK) Positive non-small cell lung cancer patients receive adjuvant treatment after complete tumor resection.
CDE Proposed Breakthrough Therapy List
1. TAEST16001 has been included in the "Breakthrough Therapy Designation" public announcement by the CDE for the treatment of soft tissue sarcoma with the HLA-A*02:01 tissue genotype and positive expression of the tumor antigen NY-ESO-1. The public announcement period is from July 22, 2024, to July 29, 2024.
2. Sutent has been included in the "Breakthrough Therapy Designation" public announcement by the CDE for the proposed treatment of locally advanced or metastatic non-small cell lung cancer (limited to non-resistant rare types).EGFRMutations, including L861Q, G719X and/or S768I). The public announcement period is from July 24, 2024 to July 31, 2024.
The above drugs have been updated to this official account: 【Patient Entrance】>【Drug Inquiry】portal, where you can go to check more approved drug information.
Data Source
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-multiple
[2] https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240705153402194.html
[3] July 22, 2024 - July 29, 2024 CDE Breakthrough Therapy Announcement - CXSL1800128
[4] July 24, 2024 - July 31, 2024 CDE Breakthrough Therapy Announcement - CXHL1402152
