(Total Views: 574)
Posted On: 05/18/2020 2:43:54 PM
Post# of 153940
Great FDA news for CYDY longs....I realize this is not exactly apples to apples but approval of a P1/2 trial of just 28 patients bodes very very well for us.
Last Friday the FDA approved Pomalyst for AIDS-Related and HIV-Negative Kaposi Sarcoma based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial.
The FDA granted the agent accelerated approval based on overall response rates observed in a phase 1/2 open label, single-arm clinical trial designed to evaluate the safety, pharmacokinetics and efficacy of Pomalyst in 28 patients with HIV-positive and HIV-negative symptomatic Kaposi sarcoma, the majority of whom had advanced disease.
The overall response rate was 71% with four patients experiencing a complete response and 16/28 achieving a partial response. The median duration of response for all patients was 12.1 months, and half of the patients who responded maintained a response at more than 12 months.
Side effects included decreased white blood cells; elevated glucose; rash; constipation; fatigue; decreased hemoglobin, platelets, phosphate, albumin or calcium; increased alanine aminotransferase (an enzyme found in the liver); nausea; and diarrhea.
Last Friday the FDA approved Pomalyst for AIDS-Related and HIV-Negative Kaposi Sarcoma based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial.
The FDA granted the agent accelerated approval based on overall response rates observed in a phase 1/2 open label, single-arm clinical trial designed to evaluate the safety, pharmacokinetics and efficacy of Pomalyst in 28 patients with HIV-positive and HIV-negative symptomatic Kaposi sarcoma, the majority of whom had advanced disease.
The overall response rate was 71% with four patients experiencing a complete response and 16/28 achieving a partial response. The median duration of response for all patients was 12.1 months, and half of the patients who responded maintained a response at more than 12 months.
Side effects included decreased white blood cells; elevated glucose; rash; constipation; fatigue; decreased hemoglobin, platelets, phosphate, albumin or calcium; increased alanine aminotransferase (an enzyme found in the liver); nausea; and diarrhea.
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