Update for March 29, 2022

Regulatory Update
 
The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis), on 3/23/2022, for the treatment of prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. Lutetium Lu 177 vipivotide tetraxetan was formerly referred to as 177Lu-PSMA-617. The FDA has also approved gallium Ga 68 gozetotide injection (Locametz, Novartis), a radiolabeling diagnostic agent used to identify PSMA-positive lesions through a positron emission tomography (PET) scan.
 
The FDA followed the ODAC’s recommendation and rejected sintilimab and recommended a multiregional trial that uses a non-inferiority design with an overall survival endpoint before re-submitting the drug.
 
The FDA rejected zandelisib and recommended a Phase III trial to support safety and efficacy.
 
The FDA accepted the re-submitted BLA for teplizumab for the delay of clinical type 1 diabetes in at-risk patients and set a PDUFA date for 8/17/2022. 
 
An FDA review of AMX0035 found weak evidence to support efficacy due to loss of patients, the potential for unblinding from adverse effects and only a modest p-value using non-preferred analysis methods. The FDA did not find the open-label, long-term extension data to support a survival benefit.
 
Announced Research Updates
 
Protalix announced results from the Phase III BRIGHT trial, evaluating the impacet of switching Fabry disease patients from agalsidase alfa or beta to pegunigalsidase alfa
 
ImmunoGen announced results from the SORAYA trial, evluating mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer.
 
Sangamo announced one-year interim results for four Fabry disease patients treated with a single infusion of the gene therapy, isaralgagene civaparvovec.
 
Pfizer announced results from the ELEVATE UC 12 trial, evaluating etrasimod in the treatment of ulcerative colitis in patients who had failed or were intolerant to at least one conventional biologic, or JAK therapy.
 
UCB announced open-label, long-term extension data from the Phase IIIB, BE RADIANT trial, bimekizumab in the treatment of moderate-to-severe chronic plaque psoriasis.
 
Lilly announced the Phase III, ADvocate 1 & 2 trials, evaluating lebrikizumab in the treatment of moderate-to-severe atopic dermatitis.
 
Published Research Updates
 
The results from the Phase III, NRG-GY004 trial were published describing the effect of olaparib on the treatment ofplatinum-sensitive relapsed ovarian cancer. 
 
Long-term results from the explorer4 and explorer5 trials were published evaluating the effect of treatment with concizumab on the annualized bleeding rate in hemophilia A.