If Leronlimab gets approval for one cancer indicat
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Posted On: 09/15/2019 6:07:15 AM
If Leronlimab gets approval for one cancer indication, it probably will be used off-label in many others with the many different phase 2s they plan on filing. I wouldn’t be surprised to see off-label in cancer with just HIV approval and good data showing CTCs numbers being reduced with leronlimab. CYDY using the ctc biomarker, approval will come much earlier. That is one of the main items RP contributed that should give leronlimab a huge leg up with approval before any of the others. First to approval, better safety, better technology, it is hard to see a path were leronlimab isn’t the industry leader imo.
https://www.bmj.com/content/360/bmj.k668
Results 47 drugs initially approved by the FDA between 2011 and 2015 for adult hematologic or solid cancers were examined. These 47 drugs were authorized for 69 FDA approved indications, whereas the NCCN recommended these drugs for 113 indications, of which 69 (62%) overlapped with the 69 FDA approved indications and 44 (39%) were additional recommendations. The average number of recommendations beyond the FDA approved indications was 0.92. 23% (n=10) of the additional recommendations were based on evidence from randomized controlled trials, and 16% (n=7) were based on evidence from phase III studies. During 21 months of follow-up, the FDA granted approval to 14% (n=6) of the additional recommendations.
Conclusion The NCCN frequently recommends beyond the FDA approved indications even for newer, branded drugs. The strength of the evidence cited by the NCCN supporting such recommendations is weak. Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence.
In an analysis of the 10 most commonly used cancer drugs, 30% of use was off-label, accounting for $4.5bn (£3.2bn; €3.6bn) in spending.2 Among off-label use, 46% (14/30), accounting for $2bn, was supported by guidelines from the National Comprehensive Cancer Network (NCCN).
One study looked at a sample of 14 off-label recommendations and found they were supported by just one phase III study, 42 phase I or II studies, and three case reports.
https://www.bmj.com/content/360/bmj.k668
Results 47 drugs initially approved by the FDA between 2011 and 2015 for adult hematologic or solid cancers were examined. These 47 drugs were authorized for 69 FDA approved indications, whereas the NCCN recommended these drugs for 113 indications, of which 69 (62%) overlapped with the 69 FDA approved indications and 44 (39%) were additional recommendations. The average number of recommendations beyond the FDA approved indications was 0.92. 23% (n=10) of the additional recommendations were based on evidence from randomized controlled trials, and 16% (n=7) were based on evidence from phase III studies. During 21 months of follow-up, the FDA granted approval to 14% (n=6) of the additional recommendations.
Conclusion The NCCN frequently recommends beyond the FDA approved indications even for newer, branded drugs. The strength of the evidence cited by the NCCN supporting such recommendations is weak. Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence.
In an analysis of the 10 most commonly used cancer drugs, 30% of use was off-label, accounting for $4.5bn (£3.2bn; €3.6bn) in spending.2 Among off-label use, 46% (14/30), accounting for $2bn, was supported by guidelines from the National Comprehensive Cancer Network (NCCN).
One study looked at a sample of 14 off-label recommendations and found they were supported by just one phase III study, 42 phase I or II studies, and three case reports.
(2)
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