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Posted On: 10/05/2025 12:00:52 PM
Post# of 157730
Examples of anti-PD-1 monoclonal antibodies
Nivolumab (Opdivo): A fully human anti-PD-1 monoclonal antibody.
Pembrolizumab (Keytruda): A humanized anti-PD-1 monoclonal antibody.
Cemiplimab (Libtayo): Another approved anti-PD-1 monoclonal antibody.
Sintilimab: An anti-PD-1 antibody shown to have high binding affinity and anti-tumor effects.
Toripalimab: An anti-PD-1 antibody known for its high binding affinity and ability to activate T cells.
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Sintilimab was jointly developed and is co-owned by Innovent Biologics and Eli Lilly
Shanghai Junshi Biosciences developed toripalimab, a PD-1 antibody, and has granted Coherus BioSciences the rights for commercialization and development in the U.S. and Canada, where it is known as LOQTORZI
Regeneron Pharmaceuticals now fully owns Cemiplimab (Libtayo) after purchasing Sanofi's stake in the drug, which was originally developed and marketed under a collaboration between the two companies.
Nivolumab is owned by Bristol Myers Squibb, who also owns the brand name for the drug, Opdivo, which they developed in partnership with Ono Pharmaceutical.
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How FDA Approvals for Metastatic Tumors Work
1) Biomarker Identification: The FDA approval process for metastatic cancer focuses on identifying specific molecular or genetic targets within the tumor.
2) Targeted Therapies: Drugs are then approved for patients whose tumors have these specific characteristics,
such as:
Gene fusions: For example, selpercatinib was approved for solid tumors with a rearranged during transfection (RET) gene fusion.
Specific mutations: Such as inavolisib for PIK3CA-mutated breast cancer or osimertinib for EGFR mutations in lung cancer.
Receptor status: Such as Enhertu for HER2-low/ultralow breast cancer.
3) Companion Diagnostics: The FDA often approves companion diagnostic tests to identify patients with the specific biomarker needed to guide treatment decisions.
4) Clinical Trials: Approval is based on clinical trials showing that the targeted therapy improves outcomes, such as overall response rate, duration of response, or progression-free survival.
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2022 video, Scott Kelly said MD Anderson was conducting synergistic combos of LL / ICI's
Only reason i can find/think of that points to why Dr. J so far says ---- "any ICI"
mTNBC trial protoccol is going to be very interesting
Nivolumab (Opdivo): A fully human anti-PD-1 monoclonal antibody.
Pembrolizumab (Keytruda): A humanized anti-PD-1 monoclonal antibody.
Cemiplimab (Libtayo): Another approved anti-PD-1 monoclonal antibody.
Sintilimab: An anti-PD-1 antibody shown to have high binding affinity and anti-tumor effects.
Toripalimab: An anti-PD-1 antibody known for its high binding affinity and ability to activate T cells.
___
Sintilimab was jointly developed and is co-owned by Innovent Biologics and Eli Lilly
Shanghai Junshi Biosciences developed toripalimab, a PD-1 antibody, and has granted Coherus BioSciences the rights for commercialization and development in the U.S. and Canada, where it is known as LOQTORZI
Regeneron Pharmaceuticals now fully owns Cemiplimab (Libtayo) after purchasing Sanofi's stake in the drug, which was originally developed and marketed under a collaboration between the two companies.
Nivolumab is owned by Bristol Myers Squibb, who also owns the brand name for the drug, Opdivo, which they developed in partnership with Ono Pharmaceutical.
___
How FDA Approvals for Metastatic Tumors Work
1) Biomarker Identification: The FDA approval process for metastatic cancer focuses on identifying specific molecular or genetic targets within the tumor.
2) Targeted Therapies: Drugs are then approved for patients whose tumors have these specific characteristics,
such as:
Gene fusions: For example, selpercatinib was approved for solid tumors with a rearranged during transfection (RET) gene fusion.
Specific mutations: Such as inavolisib for PIK3CA-mutated breast cancer or osimertinib for EGFR mutations in lung cancer.
Receptor status: Such as Enhertu for HER2-low/ultralow breast cancer.
3) Companion Diagnostics: The FDA often approves companion diagnostic tests to identify patients with the specific biomarker needed to guide treatment decisions.
4) Clinical Trials: Approval is based on clinical trials showing that the targeted therapy improves outcomes, such as overall response rate, duration of response, or progression-free survival.
___
2022 video, Scott Kelly said MD Anderson was conducting synergistic combos of LL / ICI's
Only reason i can find/think of that points to why Dr. J so far says ---- "any ICI"
mTNBC trial protoccol is going to be very interesting
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