The oral medication was rejected by the FDA panel 9 to 4 due to its low efficacy, high degree of side effects, and lack of dose optimisation.
On Thursday, advisors to the US Food and Medicine Administration decided against endorsing an investigational drug from Spectrum Pharmaceuticals (SPPI.O) for the treatment of people with a specific type of non-small cell lung cancer. The FDA stated in a session briefing document that Pozenveo may not “provide a meaningful advantage over available therapies.” The mentioned oral medication Poziotinib, was rejected by the FDA panel 9 to 4 due to its low efficacy, high degree of side effects, and lack of dose optimisation.
Pozenveo’s “poorly tolerated safety profile,” which required dose reductions in 57% of patients and resulted in 85% of patients reporting serious or life-threatening side events, was another reason given by the FDA. To solve this issue, Spectrum has suggested researching various dosing schedules, although those findings are still in the future because enrollment in the trials hasn’t started yet. The panel’s conclusion was consistent with briefing materials made public by the drug regulator on Tuesday, which expressed worries about the treatment’s efficacy in comparison to those of already available medications like Daiichi Sankyo’s (4568.T) and AstraZeneca’s Enhertu.
According to the documents, if the treatment is awarded rapid approval, it will be “the least effective targeted therapy for lung cancer approved to date” due to concerns about dose, efficacy, and the delay in benefit confirmation.
Scott Waldman, a panelist and the head of Thomas Jefferson University’s Department of Pharmacology, Physiology, and Cancer Biology, made this statement: “Clearly there’s a clinically unmet need for the drug. The drug has activity, but I don’t know that it has a meaningful improvement over other drugs that in the real world are available to patients right now.”
In a statement, Spectrum Chief Executive Officer Tom Riga expressed regret with the meeting’s outcome and stated that as the FDA decision date approaches, the company plans to carefully review its alternatives for this initiative.
By Nov. 24, the regulator is anticipated to have decided definitively on Spectrum’s medication. Although it is not required, the FDA typically heeds the advice of its independent experts.
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