Update for the Week Ending April 11, 2020

Regulatory Update

The FDA approved selumetinib (Koselugo, AstraZeneca) on 4/10/2020 for the treatment of pediatric patients with neurofibromatosis type 1.

The FDA granted sacituzumab govitecan Fast Track status for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a checkpoint inhibitor and a platinum containing chemotherapy. Immunomedics stopped the Phase III, ASCENT trial early, due to a recommendation of the Data Safety Monitoring Committee, which found compelling evidence of efficacy as seen when sacituzumab govitecan improved progression-free survival in patients with metastatic triple-negative breast cancer.
 
The FDA granted Fast Track status to balstilimab for the treatment of cervical cancer.
 
The FDA designated sotatercept a Breakthrough Therapy for the treatment of pulmonary arterial hypertension.
 
Alnylam completed a rolling NDA and submitted an MAA in April 2020 for lumasiran for the treatment of primary hyperoxaluria type 1.
 
AZ is planning to file an NDA for anifrolumab for the treatment of systemic lupus erythematosus by the end of 2020.
 
Published Research Updates
 
In a 12-week, 303 patient, Phase IIb trial, Assessment in Spondyloarthritis International Society 40% (ASAS40) was achieved in 29.5% of patients treated with 16 mg of bimekizumab, 42.6% with 64 mg, 46.7% with 160 mg and 45.9% with 320 mg compared to 13.3% with placebo in patients with Ankylosing Spondylitis. 
 
In the 1,118, Phase III MYSTIC trial, tremelimumab plus durvalumab did not improve overall survival or progression free survival compared to a platinum-based chemotherapy in patients with metastatic non-small cell lung cancer. 
 
In the 24-week, 381 pateint, Phase III, DISCOVER-1 trial, ACR20 was achieved by 64% of patients treated with guselkumab every four weeks and 64% with treatment given every 8 weeks compared to 33% of placebo patients in patients with psoriatic arthritis. In the 24-week, 739 pateint, Phase III, DISCOVER-2 trial, ACR20 was achieved by 59% of patients treated with guselkumab every four weeks and 52% with treatment given every 8 weeks compared to 22% of placebo patients in biologic-naive patients with psoriatic arthritis.