Loqtorzi FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 30, 2023.
FDA Approved: Yes (First approved October 27, 2023)
Brand name: Loqtorzi
Generic name: toripalimab-tpzi
Dosage form: Injection
Company: Coherus BioSciences, Inc.
Treatment for: Nasopharyngeal Carcinoma
Loqtorzi (toripalimab-tpzi) is a programmed death receptor-1 (PD-1)- blocking antibody used for the treatment of nasopharyngeal carcinoma.
- Loqtorzi is indicated:
- in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma.
- as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. - Nasopharyngeal carcinoma (NPC) is an aggressive type of squamous cell carcinoma of the epithelial tissue of the nasopharynx. Surgery is rarely an option in NPC due to the location of the primary tumor, and treatment usually consists of radiation and chemotherapy.
- Loqtorzi contains toripalimab-tpzi, a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that works by blocking the PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.
- FDA approval of Loqtorzi was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study.
- In the JUPITER-02 Phase 3 study, Loqtorzi combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. Loqtorzi also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
- In the POLARIS-02 clinical study Loqtorzi demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile. - Loqtorzi is administered by intravenous infusion over 60 minutes for the first infusion, and over 30 minutes for subsequent infusions (if there if are no infusion-related reactions after the first infusion).
- Warnings and precautions associated with Loqtorzi include immune-mediated adverse reactions, infusion-related reactions, complications in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT), and fetal harm.
- Common adverse reactions when used in combination with cisplatin and gemcitabine include nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise.
Common adverse reactions when used as a single agent include fatigue, hypothyroidism and musculoskeletal pain.
Development timeline for Loqtorzi
Further information
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