Notizie Newsletter
Entrectinib Breaks Through With Japanese Approval for NTRK-Positive Tumors
June 18, 2019 - Entrectinib received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the drug for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors. The ...Leggi tutto
Quizartinib Receives Japanese Approval in Relapsed/Refractory FLT3+ AML
June 18, 2019 - The Ministry of Health, Labor and Welfare (MHLW) of Japan has approved quizartinib for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia (AML), as detected by an MHLW-approved assay. The approval of the ...Leggi tutto
FDA Approves Pembrolizumab for Metastatic SCLC
June 18, 2019 - The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer (SCLC) who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy. ...Leggi tutto
Frontline Maintenance Olaparib Approved in Europe for Ovarian Cancer
June 18, 2019 - The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete ...Leggi tutto
FDA Approves Fifth Trastuzumab Biosimilar
June 13, 2019 - The FDA has approved ABP 980 (trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth ...Leggi tutto
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019
June 14, 2019 - EMA’s safety committee (PRAC) has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the ...Leggi tutto