ScienceFirst wrote: They never got FDA approval because they never did a Ph. 2 in the US.
...
Although ALA-PDT is yet to be approved for use as a treatment for bladder cancer, it is a highly accurate and minimally invasive procedure that is widely applicable and may replace Bacillus Calmette-Guerin (BCG) intravesical therapy for bladder CIS.
In addition to 5-ALA, HAL, and a hematoporphyrin derivative Photofrin® (porfimer sodium), various photosensitizers have been examined for use in PDT for bladder cancer. They include Fotolon® (chlorin e6), which is nonaromatic, unlike porphyrin, as well as a chlorine derivative, Radachlorin®.47
July 2013:
Materials and Methods:
Between July 2009 and December 2011 photodynamic therapy was performed in 22 men and 12 women. Radachlorin (0.5 to 0.6 mg/kg) was injected intravenously 2 to 3 hours before photodynamic therapy. After complete transurethral resection, a diffuser using a 22Fr cystoscope was placed in the bladder for irradiation with a 662 nm laser. Output beam power was adjusted to 1.8 W and the light dose was 15 J/cm2. Photodynamic therapy was performed for 16 to 30 minutes. Recurrence after photodynamic therapy was followed by regular cystoscopy at 1, 2 and 3 months, and at 3-month intervals thereafter for up to 2.8 years. Efficacy was assessed by cystoscopy, cytology and histology, and defined as the number of patients who were tumor free after initial photodynamic therapy.
Results:
Mean ± SD patient age was 62.94 ± 8.71 years. Average followup was 26.74 ± 6.34 months (median 28.12). As the primary efficacy outcome, the recurrence-free rate was 90.9% at 12 months, 64.4% at 24 months and 60.1% at 30 months. As the secondary efficacy outcome, there was no statistical difference in mass size, carcinoma in situ, number of previous bacillus Calmette-Gurin administrations, number of transurethral bladder resections or tumor multiplicity on Kaplan-Meier analysis (each p >0.05). No evidence of severe adverse effects was detected after photodynamic therapy.
Conclusions:
Photodynamic therapy with Radachlorin is a safe, effective treatment for nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Gurin therapy in select patients.
June 2020:
It is not FDA approved:
Fig. 1.
Radachlorin® MHRF approved 662 Russia Skin
TLD-1433 Ru Phase 2 520 Canada Bladder, brain
or bladder cancer, it is a highly accurate and minimally invasive procedure that is widely applicable and may replace Bacillus Calmette-Guerin (BCG) intravesical therapy for bladder CIS.
In addition to 5-ALA, HAL, and a hematoporphyrin derivative Photofrin® (porfimer sodium), various photosensitizers have been examined for use in PDT for bladder cancer. They include Fotolon® (chlorin e6), which is nonaromatic, unlike porphyrin, as well as a chlorine derivative, Radachlorin®.47
July 2013:
Materials and Methods:
Between July 2009 and December 2011 photodynamic therapy was performed in 22 men and 12 women. Radachlorin (0.5 to 0.6 mg/kg) was injected intravenously 2 to 3 hours before photodynamic therapy. After complete transurethral resection, a diffuser using a 22Fr cystoscope was placed in the bladder for irradiation with a 662 nm laser. Output beam power was adjusted to 1.8 W and the light dose was 15 J/cm2. Photodynamic therapy was performed for 16 to 30 minutes. Recurrence after photodynamic therapy was followed by regular cystoscopy at 1, 2 and 3 months, and at 3-month intervals thereafter for up to 2.8 years. Efficacy was assessed by cystoscopy, cytology and histology, and defined as the number of patients who were tumor free after initial photodynamic therapy.
Results:
Mean ± SD patient age was 62.94 ± 8.71 years. Average followup was 26.74 ± 6.34 months (median 28.12). As the primary efficacy outcome, the recurrence-free rate was 90.9% at 12 months, 64.4% at 24 months and 60.1% at 30 months. As the secondary efficacy outcome, there was no statistical difference in mass size, carcinoma in situ, number of previous bacillus Calmette-Gurin administrations, number of transurethral bladder resections or tumor multiplicity on Kaplan-Meier analysis (each p >0.05). No evidence of severe adverse effects was detected after photodynamic therapy.
Conclusions:
Photodynamic therapy with Radachlorin is a safe, effective treatment for nonmuscle invasive bladder cancer refractory or intolerant to bacillus Calmette-Gurin therapy in select patients.