Spectrum Pharmaceutecals Inc (SPPI)

[BarrellofHay]

Hi Anti, is it me or is the FDA completely 100% wrong about the following statement from their report:

"For accelerated approval, efficacy should demonstrate a meaningful advantage over available therapy. Poziotinib demonstrated limited anti-tumor activity similar to that of available chemotherapy combination therapy and of shorter duration than was observed with immunotherapy in patients who had not previously received an immune checkpoint inhibitor.
– The ORR observed in 90 patients enrolled in Cohort 2 of ZENITH20 who received poziotinib 16 mg QD was 28% (95% CI: 19, 38), with a median DOR of 5.1 months (95% CI: 4.2, 5.5). As of a data cutoff date (DCO) of March 5, 2021, 24% of responders had a response duration of ≥ 6 months. For the subgroup of patients who received both platinum-based chemotherapy and an immune checkpoint inhibitor (N=59), the ORR was 25% (95% CI: 15, 38), with a median DOR of 5.1 months (95% CI: 3.1, 6.6)."

They state that the chemotherapy/checkpoint "subgroup" of 59 patients had an ORR of 25% and that the ORR of the entire Cohort study was ~28% and they are not that different. Wait a minute. !!!! This is not the ORR for a COMPARATIVE subgroup that received chemo/checkpoint as the ONLY second line treatment. Right?? This is the ORR of Pozi on that first line chemo/checkpoint subgroup.

In other words they are confused that the 25% ORR was for second line treatment with chemo/checkpoint only without POZI. This is not true, this is the ORR for Poziotinib on that subgroup AFTER treatment.

https://ascopubs.org/doi/full/10.1200/JCO.21.01323#
Figure 2

Am I completely confused here?? Or is the FDA review committee so off base on such a simple comparative that they could risk rejection of a drug, lives of hundreds to thousands of people and literally billions in sharholder value??