Update for September 28, 2021

Regulatory Update
 
The FDA approved tisotumab vedotin (Tivdak, Seagen and Genmab), on 9/20/2021, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The prescribing information for tisotumab includes a BOXED WARNING for ocular toxicity, and Warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. 
 
The FDA granted ficlatuzumab a fast-track designation as a treatment for relapsed or recurrent head and neck squamous cell carcinoma.
 
The FDA granted lanifibranor a fast-track designation as a treatment for non-alcoholic steatohepatitis with compensated cirrhosis.
 
Announced Research Updates
 
Pfizer and Lilly announced that in a 24-week, 145 patient, Phase III trial, patients treated with tanezumab had a 3.03 point decrease in their pain intensity score at eight-weeks compared to a 1.25 point decrease with placebo in patients with cancer that had metastasized to the bone or multiple myeloma, who were receiving optimized opioids. However, the difference in pain scores was not significant after eight weeks.
 
Astellas announced that in the 12-week, 501 patient, Phase III, SKYLIGHT 2 trials, patients treated with fezolinetant reduced the severity of moderate to severe vasomotor symptoms (VMS) by 0.15 points at 4 weeks and 0.16 points at 12 weeks with 30 mg and 0.29 points at 4 weeks and 12 weeks with 45 mg compared to placebo in patients with moderate to severe VMS. The frequency of moderate to severe VMS events per day versus placebo was reduced by 1.82 events at 4 weeks and 1.86 events at 12 weeks with 30 mg and 2.55 events and 2.53 events with 45 mg compared to placebo
 
Novan announced that in the 12-week, 891 patient, Phase III, B-SIMPLE4 trial, 32.5% of patients treated with SB206 achieved complete clearance of all treatable molluscum lesions compared to 19.7% with placebo in patients with molluscum contagiosum.
 
Biohaven announced that in a 48-week, 336 patient, Phase III trial, treatment with verdiperstat did not improve the Unified Multiple System Atrophy Rating Scale compared to placebo in patients with Multiple System Atrophy.
 
Published Research Updates
 
In a 24-week, 118 patient, Phase II, open label trial, treatment with pemafibrate did not decrease the magnetic resonance imaging-estimated proton density fat fraction at 24-weeks, but did decrease MRE-based liver stiffness at 72-weeks compared to placebo in patients with high-risk, non-alcoholic fatty liver disease.
 
In the 12-week, 496 patient, Phase III REFALS trial, treatment with levosimendan did not improve the slow vital capacity in the supine position compared to placebo in patients with ALS. 
 
In a seven-day, 16 patient, cross-over, Phase II trial, 81% of patients treated with reboxetine had a least a 50% reduction in apnea-hypopnea index compared to 13% with placebo in patients with obstructive sleep apnea.
 
In the 104-week, 836 patient, open-label, Phase III, PYRENEES trial, roxadustat was non-inferior to erythropoiesis-stimulating agent (epoetin alfa or darbepoetin alfa) for changes in hemoglobin at weeks 36 and 52 in CKD patients on dialysis.
 
In a 378 patient, Phase II trial, where treatment with tebentafusp resulted in overall survival of 73% compared to 59% with investigator choice of pembrolizumab, ipilimumab, or dacarbazine in patients with previously untreated HLA-A*02:01–positive patients with metastatic uveal melanoma.