RE:RE:RE:RE:Trodelvy improved PFS by 34% in heavily pre-treated patientsONCY's pelareorep is considered a new class of treatment for this and other indications and would appear a much better side effect and QoL profile than Trodelvy as determined by the 5 point ESMO-MCBS scoring guidelines of decision making in clinical practice.
https://www.esmo.org/guidelines/esmo-mcbs/about-the-esmo-mcbs
TRODELVY side effects include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.
The FDA's Accelerated Approval is intended to be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval.
https://www.fda.gov/drugs/development-approval-process-drugs
ONCY's pelareorep has a signficant benefit in the treatment of HR+/HER2- metastatic breast cancer in that pelareorep has a better QoL and safer side effect profile and would provide a significant benefit over Gilead's Trodelvy