This is the question that has been nagging me for a few days. It's our safety profile. Leronlimab's safety profile is the best! Hands down, it is more safe that aspirin, with less contraindications. I keep running into the first rule of "Do no harm" as consideration criteria for the FDA. From YMB:
Chad
"As a physician, I don’t understand why leronlimab was not granted breakthrough therapy designation (BTD) for treatment of metastatic triple negative breast cancer. In the study of Trodelvy, side effects such as neutropenia, diarrhea, and anemia were more common compared to standard chemotherapy. Neutropenia, an abnormally low count of neutrophils, places one at risk for infections which may be severe and even fatal. Diarrhea with Trodelvy can be severe. Per the FDA website, BTD can be granted based on improvement in a clinically significant endpoint such as “a significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy.” Even if leronlimab lacks greater efficacy, does it not have a better safety profile? Am I missing something here?
As a disclosure, I am long leronlimab"
Chad
"As a physician, I don’t understand why leronlimab was not granted breakthrough therapy designation (BTD) for treatment of metastatic triple negative breast cancer. In the study of Trodelvy, side effects such as neutropenia, diarrhea, and anemia were more common compared to standard chemotherapy. Neutropenia, an abnormally low count of neutrophils, places one at risk for infections which may be severe and even fatal. Diarrhea with Trodelvy can be severe. Per the FDA website, BTD can be granted based on improvement in a clinically significant endpoint such as “a significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy.” Even if leronlimab lacks greater efficacy, does it not have a better safety profile? Am I missing something here?
As a disclosure, I am long leronlimab"
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