Update for February 1, 2022

Regulatory Update
 
The FDA approved faricimab (Vabysmo, Genentech/Roche), on 1/28/2022, to treat diabetic macular edema and neovascular age-related macular degeneration.
 
The FDA approved tebentafusp (Kimmtrak, Immunocore), on 1/26/2022, for the treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma. Tebentafusp was approved with a black boxed warning for cytokine release syndrome.
 
Provention Bio satisfied FDA concerns for the dosing and equivalence of the AGC Biologics manufactured templizumab. A new BLA submission will also address Chemical, Manufacturing, and Controls (CMC) and product quality questions from the FDA rejection in 2021. Provention Bio plans to resubmit a BLA for templizumab in 1Q22.
 
Incyte has discontinued its request for accelerated approval of parsaclisib for the treatment of relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, because the company felt it would be too difficult to complete required confirmatory studies to convert the accelerated approval to a full approval.
 
The FDA paused trials evaluating the combination of magrolimab and azacitidine due to adverse reactions seen with the combination. The pause did not affect trials evaluating magrolimab alone or in combination with other chemotherapy.
 
The FDA placed a partial hold on studies evaluating the combination of umbralisib and ublituximab in the treatment of chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.
 
The FDA designated eplontersen an Orphan Drug for the treatment of transthyretin-mediated amyloidosis.
 
Announced Research Updates
 
Sierra announced results of the MOMENTUM trial evaluating momelotinib in the treatment of myelofibrosis.
 
Madrigal announced results from the MAESTRO-NAFLD-1 trial where resmetirom was evaluated for the treatment of NASH.
 
Published Research Updates
 
Delgocitinib was evaluated in a Phase IIb chronic hand eczema trial
 
Plinabulin was compared to pegfilgrastim to prevent grade 4 neutropenia in the PROTECTIVE-1 trial.
 
The BrighTNess trial evaluated the effect of adding veliparib to carboplatin in patients with triple-negative breast cancer.
 
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