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Summit Therapeutics (SMMT)
NASDAQ:SMMT
Ivonescimab Injection, Pembrolizumab Injection
Non-small Cell Lung Cancer
Phase III
Recruiting
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Jan 03, 2025
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Ivonescimab Injection, Pembrolizumab Injection
Non-small Cell Lung Cancer
Phase III
Recruiting
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Jun 01, 2023
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Oxaliplatin, Irinotecan, Capecitabine, Leucovorin, 5-Fluorouracil, Ak112, Ak117
Metastatic Colorectal Cancer
Phase II
Active Not Recruiting
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
May 16, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Summit Therapeutics (SMMT) have in its pipeline
SMMT is currently developing the following drugs: Ivonescimab Injection, Pembrolizumab Injection, Ivonescimab Injection, Pembrolizumab Injection, Oxaliplatin, Irinotecan, Capecitabine, Leucovorin, 5-Fluorouracil, Ak112, Ak117. These drug candidates are in various stages of clinical development as the company works toward FDA approval.