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Cancer therapies: Immune checkpoint inhibitors may kill you

Posted on October 21, 2018 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Research, New Safety Information, Thasso Post, Theragenomic Medicine No Comments ↓

October 21, 2018 – In a study published online September 13 in JAMA Oncology, the authors just reminded us of the fact that besides all hype about immune checkpoint inhibitors (ICIs) in the cancer therapy field,

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Tags: Autoimmunity, CTLA-4 Gene, Fatal Adverse Drug Reaction (FADR), Fatal Colitis, Fatal Hepatitis, Fatal Myocarditis, Fatal Neurological Events, Fatal Pneumonitis, French National Alliance for Life and Health Sciences (AVIESAN), Immune Checkpoint Inhibitors (ICI's), Immune-Related Adverse Drug Reactions (irADRs), Ipilimumab [Yervoy], Nivolumab (Opdivo), Pembrolizumab [Keytruda], Programmed Cell Death–1/Ligand-1 (PD-1/PD-L1), Remove term: Fatal Adverse Drug Reaction (FADR) Fatal Adverse Drug Reaction (fADR), Uppsala Monitoring Center (UMC), VigiBase, World Health Organization (WHO)

Pembrolizumab (Keytruda): Clinical trials on hold

Posted on September 2, 2017 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], Regulatory Announcement, Thasso Post, Theragenomic Medicine 2 Comments ↓

September 2, 2017 – The American Food & Drug Administration (FDA) has announced that two clinical trials with Pembrolizumab (Keytruda) in patients with multiple myeloma have been put on hold. The FDA informs the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (Lenalidomide (Revlimid) or Pomalidomide (Pomalyst)) for the treatment of patients with multiple myeloma.

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Tags: American Food & Drug Administration (FDA), Checkpoint Inhibitor, Clinical Hold, Clinical Trial, Immunemodulation, Lenalidomide [Revlimid], Multiple Myeloma, PD-1/PD-L1 Inhibitor, Pembrolizumab [Keytruda], Pomalidomide (Pomalyst), Thasso Post, Theragenomic Medicine

Biomarker-guided Larotrectinib for all cancer types?

Posted on June 9, 2017 by by

thassodotcom Posted in Genetic Background, Genetic Predisposition, New Research, On The Horizon, Personalized Medicine, Targeted Therapy, Thasso Post, Theragenomic Medicine 1 Comment ↓

June 09, 2017 – It’s only a couple of days that the American Food & Drug Administration (FDA) approved for the first time a cancer treatment for any solid tumor, irrespective of the tumor’s original location, as long as the targeted tumor is carrying a specific genetic feature (i.e.,

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Tags: Actionable Biomarker, Biomarker, Larotrectinib, Microsatellite Instability High (MSI-H), Mismatch Repair Deficient (dMMR), Oncogene, Oral Tumor-Agnostic Therapy, Pembrolizumab [Keytruda], Thasso Post, Theragenomic Medicine, Tropomyosin Receptor Kinase (TRK) Fusion

First cancer treatment for any solid tumor with MSI-H or dMMR approved

Posted on May 24, 2017 by by

thassodotcom Posted in Genetic Background, New Indication Approval, Personalized Medicine, Regulatory Approval, Targeted Therapy, Thasso Post, Theragenomic Medicine 4 Comments ↓

May 24, 2917 – The American Food & Drug Administration (FDA) just approved a major extension of the clinical indications for Pembrolizumab (Keytruda). For the first time, a cancer treatment has been approved for any solid tumor, irrespective of the tumor’s original location, as long as the targeted tumor is carrying a specific genetic feature (i.e.,

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Tags: American Food & Drug Administration (FDA), Biomarker, Checkpoint Inhibition, Microsatellite Instability, Microsatellite Instability High (MSI-H), Mismatch Repair Deficient (dMMR), Pembrolizumab [Keytruda], Solid Tumor, Thasso Post, Theragenomic Medicine

Risk of severe if not fatal skin reactions with Pembrolizumab (Keytruda)

Posted on March 21, 2017 by by

thassodotcom Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine No Comments ↓

March 21, 2017 – Health Canada just communicated this important safety information: Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) under treatment of patients with Pembrolizumab (Keytruda) have been reported internationally in the clinical trials and post-marketing setting.

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Tags: Checkpoint Inhibitor, Health Canada, Pembrolizumab [Keytruda], Programmed Death Receptor-1 (PD-1, Severe Adverse Drug Reaction (ADR), Stevens Johnson Syndrome [SJS], Toxic Epidermal Necrolysis (TEN)

Mutations Associated with Acquired Resistance to PD-1 Blockade in Melanoma

Posted on September 6, 2016 by by

thassodotcom Posted in Genetic Background, New Research, On The Horizon, Thasso Post, Theragenomic Medicine No Comments ↓

September 06, 2016 – Genetic mutations associated with acquired resistance to PD-1 blockade in melanoma have been suspected to be involved in the clinical observation that while approximately 75% of objective responses to anti–programmed death 1 (PD-1) therapy in patients with melanoma are durable, lasting for years,

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Tags: Actionable Biomarker, Beta-2-Microglobulin (B2M), Immune Escape, Janus Kinase 1 (JAK1), Janus Kinase 2 (JAK2), Major Histocompatibility Complex (MHC), Pembrolizumab [Keytruda], Refractive Tumor, Relapse, Thasso Post, Theragenomic Medicine

Pembrolizumab [Keytruda] for advanced melanoma: First PD-1 blocking drug to receive approval

Posted on September 11, 2014 by by

thassodotcom Posted in New Drug Approval, Thasso Post, Theragenomic Medicine No Comments ↓

September 11, 2014 – The U.S. Food and Drug Administration today granted accelerated approval to Pembrolizumab (Keytruda) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Melanoma, which accounts for approximately 5 percent of all new cancers in the United States,

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