New Drug Update for The Week Ending July 6

Regulatory Update

The FDA approved Karyopharm Therapeutics’ selinexor (Xpovio), on 7/3/2019, in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody. In February 2019, the FDA Oncologic Drugs Advisory Committee recommend a delay in approval of selinexor-dexamethasone until after the results of the Phase III BOSTON trial were available in the first half of 2020. In March 2019, the FDA delayed the PDUFA date for selinexor by three months.

The FDA accepted the NDA for RedHill Biopharma's RHB-105 (Talicia) for the treatment of H. pylori infection and assigned a November 2, 2019 PDUFA date. RHB-105 is a combination of rifabutin, amoxicillin and omeprazole

Gilead plans to file an NDA for filgotinib by the end of 2019, for the treatment of Crohn's disease, rheumatoid arthritis, and Ankylosing spondylitis

Announced Research Updates

Boston Biomedical discontinued a Phase III trial when an interim analysis found no improvement when adding napabucasin to nab-paclitaxel with gemcitabine compared to the two drugs alone in the treatment of metastatic pancreatic ductal adenocarcinoma.

Lilly announced that a targeted investigation examining patients with cardiovascular (CV) risk factors that participated in the lasmiditan SPARTAN and SAMURAI trials found a small increase in palpitations or tachycardia as the only CV ADR, however it could not be determined if the increase was due to lasmiditan. The presence of CV risk factors did not affect efficacy. 

TG Therapeutics announced that in a 48-week, 48 patient, Phase II trial, 99% of patients treated with ublituximab achieved at least a 99% reduction in peripheral CD19+ B cells at 4 weeks, which was maintained through 48 weeks. At 48 weeks the annualized relapse was 0.07, down from a mean 1.45 relapses per year before the trial. 93% of patients were relapse free.

Published Research Updates

In a 16-week, 696 patient, Phase III trial, where compared to placebo, treatment with tanezumab decreased the WOMAC pain score by 0.6 points with 2.5mg in week 1 and 8 and a 0.73 decrease with 2.5 mg given in week 1 and 5 mg given in week 8 in patients with osteoarthritis pain of the knee and hip and an inadequate response to standard analgesics. The WOMAC Physical Function score was decreased 0.66 points with 2.5 mg and 0.89 points with 2.5/5 mg.

In a 72 patient trial, levosimendan did not reduce the occurrence rate of acute kidney injury compared to milrinone in infants after open-heart surgery with cardiopulmonary bypass.