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▎WuXi AppTec content team editor recently, Oncopeptides announced that the US FDA has accelerated the approval of Pepaxto (melphalan flufenamide, also known as melflufen) to be marketed in combination with dexamethasone to treat relapsed/refractory multiple myeloma (MM) Adult patients.
These patients have received at least four previous therapies, and the disease is resistant to at least one proteasome inhibitor, immunomodulator, and monoclonal antibody targeting CD38.
The press release states that Pepaxto is the first peptide drug conjugate approved by the FDA.
MM is a malignant blood cancer caused by abnormal proliferation of plasma cells in the bone marrow.
Cancerous plasma cells can affect the production of normal blood cells, leading to decreased blood cell index, bone damage and kidney damage.
Although in the past ten years, the emergence of innovative therapies has significantly revolutionized the treatment of MM.
However, many patients with MM will still relapse and develop resistance to existing therapies.
Therefore, these patients with relapsed/refractory MM still need new treatment options.
Pepaxto is a "first-in-class" peptide-conjugated drug that couples alkylating agents with peptides that target aminopeptidase.
Pepaxto can be quickly taken up by MM cells due to its lipophilicity.
In the cell, it will be quickly hydrolyzed by peptidase, thereby releasing the hydrophilic alkylating agent.
Aminopeptidase is overexpressed in tumor cells, especially in advanced cancers or tumors with high mutation complexes.
In in vitro experiments, Pepaxto can increase the concentration of the alkylating agent in the cell, and its ability to kill MM cells is 50 times higher than that of the alkylating agent it carries.
▲The molecular structure of Pepaxto (picture source: Ed (Edgar181) / Public domain) This approval is based on the results of the pivotal Phase 2 clinical trial HORIZON.
In this clinical trial, 157 patients with relapsed/refractory MM received a combination therapy consisting of Pepaxto and dexamethasone.
The test results showed that the combination therapy reached an overall remission rate of 23.
7%, and the median duration of remission was 4.
2 months.
"The accelerated approval of Pepaxto is an important milestone for Oncopeptides.
We aim to bring hope to patients with refractory blood diseases through scientific innovation.
" Oncopeptides CEO Marty J Duvall said, "We look forward to getting Pepaxto in Phase 3 in the second quarter.
The main data in clinical trials, and will work to further expand its scope of use.
"Note: This article is intended to introduce medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
Reference: [1] FDA approves Oncopeptides' PEPAXTO® (melphalan flufenamide) for patients with relapsed or refractory multiple myeloma.
Retrieved February 28, 2021, from https:// oncopeptides-pepaxto--melphalan-flufenamide-for-patients-with-relapsed-or-refractory-multiple-myeloma-301236751.
html
These patients have received at least four previous therapies, and the disease is resistant to at least one proteasome inhibitor, immunomodulator, and monoclonal antibody targeting CD38.
The press release states that Pepaxto is the first peptide drug conjugate approved by the FDA.
MM is a malignant blood cancer caused by abnormal proliferation of plasma cells in the bone marrow.
Cancerous plasma cells can affect the production of normal blood cells, leading to decreased blood cell index, bone damage and kidney damage.
Although in the past ten years, the emergence of innovative therapies has significantly revolutionized the treatment of MM.
However, many patients with MM will still relapse and develop resistance to existing therapies.
Therefore, these patients with relapsed/refractory MM still need new treatment options.
Pepaxto is a "first-in-class" peptide-conjugated drug that couples alkylating agents with peptides that target aminopeptidase.
Pepaxto can be quickly taken up by MM cells due to its lipophilicity.
In the cell, it will be quickly hydrolyzed by peptidase, thereby releasing the hydrophilic alkylating agent.
Aminopeptidase is overexpressed in tumor cells, especially in advanced cancers or tumors with high mutation complexes.
In in vitro experiments, Pepaxto can increase the concentration of the alkylating agent in the cell, and its ability to kill MM cells is 50 times higher than that of the alkylating agent it carries.
▲The molecular structure of Pepaxto (picture source: Ed (Edgar181) / Public domain) This approval is based on the results of the pivotal Phase 2 clinical trial HORIZON.
In this clinical trial, 157 patients with relapsed/refractory MM received a combination therapy consisting of Pepaxto and dexamethasone.
The test results showed that the combination therapy reached an overall remission rate of 23.
7%, and the median duration of remission was 4.
2 months.
"The accelerated approval of Pepaxto is an important milestone for Oncopeptides.
We aim to bring hope to patients with refractory blood diseases through scientific innovation.
" Oncopeptides CEO Marty J Duvall said, "We look forward to getting Pepaxto in Phase 3 in the second quarter.
The main data in clinical trials, and will work to further expand its scope of use.
"Note: This article is intended to introduce medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
Reference: [1] FDA approves Oncopeptides' PEPAXTO® (melphalan flufenamide) for patients with relapsed or refractory multiple myeloma.
Retrieved February 28, 2021, from https:// oncopeptides-pepaxto--melphalan-flufenamide-for-patients-with-relapsed-or-refractory-multiple-myeloma-301236751.
html
