Update for July 28, 2020

Right to Try Update

The FDA has proposed requirements for the annual report for any investigational drug provided to eligible patients under the Right to Try Act. The FDA is accepting comments on the proposed rule until 9/22/2020. 
 
Regulatory Update

The FDA approved brexucabtagene autoleucel (Tecartus, Gilead Sciences), on 7/24/2020, for the treatment of relapsed or refractory mantle cell lymphoma. Brexucabtagene autoleucel was approved with a boxed warning and REMS program due to the risks of CRS and neurologic toxicities. Brexucabtagene autoleucel is a one-time treatment and Gilead has priced the drug at $373,000, the same price as its other CAR-T cell therapy axicabtagene ciloleucel (Yescarta).
 
The FDA approved abametapir (Xeglyze, Dr. Reddy's Laboratories), on 7/24/2020, for the treatment of head lice.
 
The FDA designated MyoKardia’s mavacamten a Breakthrough Therapy for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy.
 
The FDA accepted the NDA for Aurinia Pharmaceuticals’ voclosporin for the treatment of lupus nephritis and set a PDUFA date of 1/22/2021.
 
CHMP (European new drug review committee) recommended approval of GlaxoSmithKline’s belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma, filgotinib for the treatment of rheumatoid arthritis, and bupivacaine/meloxicam for the treatment of postoperative pain.
 
Announced Research Updates

Genfit is discontinuing development of elafibranor for NASH resolution without worsening fibrosis. The company will focus the drug’s development efforts on primary biliary cholangitis.
 
Roche discontinued development of the investigational autism treatment, balovaptan, in July 2020.
 
UCB announced that in the 16-week, 743 patient, Phase IIIB, BE RADIANT trial, treatment with bimekizumab was superior to secukinumab in moderate-to-severe chronic plaque psoriasis patients achieving PASI 100.
 
Published Research Updates

In the 237 patient, Phase III RECOVER trial, 20.3% of patients treated with eflapegrastim developed severe neutropenia compared to 23.5% with pegfilgrastim during the first cycle of docetaxel/cyclophosphamide treatment of breast cancer.