Pembrolizumab, Skb264
Solid Tumor
Phase II
Active Not Recruiting
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Nov 30, 2022
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Ethanol, Melphalan, Bcnu, Vitamin B12b, Vitamin C, Autologous Hematopoietic Stem Cells
Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancreatic Cancer Stage Iv, Pancreatic Cancer, Her2-Negative Breast Cancer, Breast Cancer Metastatic, Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma Metastatic, Brca1 Mutation, Brca2 Mutation, Pancreatic Acinar Cell Carcinoma, Breast Cancer Stage Iv, Her2 Negative Breast Carcinoma, Adenocarcinoma Of The Breast, Palb2 Gene Mutation
Phase I
Recruiting
SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells
Oct 30, 2019
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Temozolomide, Pamiparib
Locally Advanced Or Metastatic Solid Tumors
Phase I
Completed
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
May 08, 2017
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Niraparib
Ovarian Neoplasms
Phase III
Active Not Recruiting
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Dec 08, 2015
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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 Myriad Genetics (MYD) have in its pipeline
MYD is currently developing the following drugs: Pembrolizumab, Skb264, Ethanol, Melphalan, Bcnu, Vitamin B12b, Vitamin C, Autologous Hematopoietic Stem Cells, Temozolomide, Pamiparib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.