Bronchitol Now Available as Add-on Maintenance Therapy for Cystic Fibrosis
Bronchitol should only be used by adults who have passed the Bronchitol Tolerance Test.
Respiratory Diseases/Disorders
Trial Evaluating Tocilizumab Plus Remdesivir for COVID-19 Pneumonia Misses End Points
The REMDACTA study evaluated the efficacy and safety of tocilizumab plus remdesivir in hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
Trial Investigating Canakinumab for Advanced or Metastatic NSCLC Misses Primary End Point
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to interleukin-1beta.
Actemra Gains New Indication for Systemic Sclerosis-Associated Interstitial Lung Disease
The FDA has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in SSc-ILD.
Lorbrena Approved for First-Line Treatment of ALK-Positive Metastatic NSCLC
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
Dupilumab Under Review for Pediatric Asthma
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
Cosela Now Available to Reduce Chemotherapy-Induced Bone Marrow Suppression in ES-SCLC
The approval was based on data from 3 randomized, placebo-controlled trials that included 245 adults with ES-SCLC.
Keytruda Indication for Metastatic Small Cell Lung Cancer Withdrawn
Continued approval of the indication was contingent upon establishing the superiority of Keytruda as determined by overall survival.
Gefapixant Under Review for Refractory Chronic Cough
The NDA submission is based on data from the double-blind, placebo-controlled phase 3 studies, COUGH-1 and COUGH-2.
Optimal Therapy for Esophageal Cancer Feasible in Fit Elderly
Those 70 years and older have similar postoperative complication scores and long-term survival.
