Imfinzi Receives Orphan Drug Designation for Small Cell Lung Cancer
The FDA has granted Orphan Drug designation to Imfinzi (durvalumab; AstraZeneca) for the treatment of small cell lung cancer (SCLC).
Respiratory and Thoracic Cancers
WHO Updates List of Essential Medicines
The World Health Organization (WHO) has updated the WHO Model List of Essential Medicines for 2019.
Adding Bevacizumab May Improve Overall Survival in NSCLC
Addition of bevacizumab to carboplatin/pemetrexed beneficial in advanced non-small cell lung cancer
Keytruda Approved to Treat Metastatic Small Cell Lung Cancer
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.
Keytruda Gains Expanded Monotherapy Indication for First-Line Treatment of NSCLC
Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Ready-to-Infuse Chemotherapy Product Infugem Now Available
Sun Pharma announced the launch of Infugem (gemcitabine in sodium chloride injection) 10mg/mL for intravenous (IV) use in a ready-to-administer (RTA) bag.
J&J Responds to “False and Inflammatory” Article Concerning Baby Powder
While the Reuters article notes that most internal J&J talc tests did not show asbestos, the report goes on to suggest that “they [J&J] have always had limitations that allow trace contaminants to go undetected.”
Tecentriq Combination Regimen Approved for Metastatic Non-Squamous NSCLC
The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1.
Higher-Volume Hospitals Have Better Laryngectomy Outcomes
Hospitals in the top-volume quintile (>28 cases per year) were associated with decreased odds of in-hospital mortality (odds ratio, 0.45), postoperative surgical complications (odds ratio, 0.63), and acute medical complications (odds ratio, 0.63).
Lorbrena Approved for Previously-Treated ALK-Positive Metastatic NSCLC
Lorbrena, a third generation ALK tyrosine kinase inhibitor (TKI), has been approved under the accelerated pathway based on tumor response rate and duration of response.
