Trastuzumab Deruxtecan Gets Priority Review for Previously Treated HER2-Mutant Metastatic NSCLC
The FDA has granted Priority Review to fam-trastuzumab deruxtecan-nxki to treat adults with previously treated HER2-mutant metastatic NSCLC.
NSCLC
Opdivo Plus Chemotherapy Approved for Neoadjuvant Treatment of Resectable NSCLC
The approval was based on data from the CHECKMATE-816 trial.
First-Line Osimertinib: Proceed With Caution in Elderly Patients With NSCLC
The high frequency of pneumonitis “is a serious concern,” according to researchers.
LncRNA DLGAP1-AS2 linked to miR-503/cyclin D1 in Non-Small Cell Lung Cancer
In non-small cell lung cancer, LncRNA DLGAP1-AS2 regulates miR-503/cyclin D1 to promote cell proliferation.
Atezolizumab Gets Priority Review as Adjuvant Treatment for Early NSCLC
The sBLA is supported by data from the IMpower010 study that compared atezolizumab with best supportive care in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy.
Adding Ipilimumab to Nivolumab No Better in Pretreated Squamous NSCLC
For patients with advanced, chemotherapy-pretreated, immune checkpoint inhibitor-naive Sq NSCLC, ipilimumab added to nivolumab does not improve outcomes versus nivolumab alone.
Pralsetinib Approved for Metastatic RET Fusion-Positive NSCLC
The FDA has approved Gavreto™ (pralsetinib; Blueprint Medicines and Genentech) for the treatment of adults with metastatic RET fusion-positive NSCLC.
Novel Bispecific Antibody Gets Breakthrough Therapy Status for NSCLC
The FDA has granted Breakthrough Therapy designation to JNJ-6372 for the treatment of patients with NSCLC with EGFR Exon 20 insertion mutations.
Brigatinib Receives Priority Review for First-Line Treatment of ALK+ Metastatic NSCLC
The Food and Drug Administration has granted Priority Review for the supplemental New Drug Application (sNDA) for brigatinib (Takeda) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
Atezolizumab Monotherapy Under Review for First-Line Advanced NSCLC Treatment
The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq®; Genentech) as a first-line monotherapy in patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.
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