The FDA weigh up mandatory education for opioid prescribers; There’s an increase in the sale of strong psychoactive THC products; Brukinsa and Exkivity gain approval, respectively; And a number of supplement companies received FDA warning letters.
The approval was based on data from 2 single-arm clinical trials in adults with relapsed or refractory marginal zone lymphoma who have received at least 1 anti-CD20-based regimen.
The approval was based on data from the phase 3 ASPEN trial.
In 2011, the FDA granted accelerated approval to Istodax, a histone deacetylase (HDAC) inhibitor, for PTCL in adults.
The FDA is requiring the manufacturer, Oncopeptides AB, suspend enrollment in the phase 3 OCEAN trial, along with other ongoing Pepaxto clinical trials.
Pronounced lag in antibody production after the first dose found versus noncancer controls
The approval was based on data from the phase 3 APOLLO trial.
Rylaze will be supplied as single-dose vials containing 10mg/0.5mL solution of asparaginase erwinia chrysanthemi (recombinant)-rywn and is expected to be available in mid-July 2021.
Seventy-five percent of patients achieved a best response of bone marrow-undetectable measurable residual disease remission
Lower 30-day mortality seen in hospitalized adults, including those admitted to ICU, requiring mechanical ventilation
