FDA has granted Fast Track Designation (FTD) to Perspective Therapeutics’ VMT01 for treating adults with MC1R-expressing unresectable or metastatic melanoma.
This decision was based on the promising results of phase 1/2a VMT01 trial, offering hope for MC1R melanoma patients.
Markus Puhlmann, CMO of Perspective Therapeutics, emphasized the FDA’s significant recognition of VMT01 for MC1R melanoma.
He acknowledged the completion of the dose-limiting toxicity observation period in 7 MC1R melanoma patients from cohort 2 of the phase 1/2a study and highlighted plans to present safety data later this year.
Additionally, pending institutional review board approval, a VMT01/anti-PD-1 combination cohort is set to open.
Perspective‘s VMT01 for MC1R melanoma was investigated in a phase 1/2 trial, recruiting across 9 locations with 52 patients enrolled.
Patients showing positive uptake of the imaging agent 203Pb VMT01 were treated with the therapeutic 212Pb VMT01.
Source: Perspective Therapeutics Granted Fast Track Designation for VMT01 for the Diagnosis and Treatment of MC1R-Positive Melanoma
https://finance.yahoo.com/news/perspective-therapeutics-granted-fast-track-110000345.html?guccounter=1
