The European Commission has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications.
FDA has accepted for review the filing of a supplemental New Drug Application for XTANDI (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer.
The Japan Ministry of Health, Labor and Welfare approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
FDA has published a draft guidance, Male Breast Cancer: Developing Drugs for Treatment, which includes recommendations for inclusion of males in breast cancer clinical trials.
FDA approved darolutamide (Nubeqa) for non-metastatic castration-resistant prostate cancer.
FDA has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma.
FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Predictive Oncology subsidiary Helomics and UPMC announced a collaborative agreement to study the use of artificial intelligence to improve clinical decision making for ovarian cancer patients.
FDA announced the launch of its first e-cigarette prevention TV ads educating kids about the dangers of e-cigarette use. FDA also plans to provide new posters for high schools and educational materials for middle schools across the U.S. as part of “The Real Cost” Youth E-Cigarette Prevention Campaign.
