Companies presented very promising data for treating lung cancer at European Society of Medical Oncology (ESMO) Congress 2021.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
Fennec Pharmaceuticals resubmitted the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration for the pediatric chemotherapy-induced hearing loss prevention drug Pedmark.
The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
AstraZeneca and Merck announced positive five-year follow-up data from the Phase III SOLO-1 trial which demonstrated a long-term progression-free survival benefit of Lynparza as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
