Darolutamide for Castration-Resistant Prostate Cancer: FDA Updates Prescribing Info

The FDA has added new overall survival and other secondary outcome data to the prescribing information for darolutamide (Nubeqa®, Bayer), an androgen receptor inhibitor which was approved for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) in 2019. The updates were based on the final analysis of the phase 3 ARAMIS trial (NCT02200614), led by first author Karim Fizazi, MD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy in Villejuif, France. The...
Continue reading

Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...
Continue reading

Darolutamide Approved in Nonmetastatic CRPC

The FDA has now approved darolutamide (Nubeqa®, Bayer), an androgen receptor antagonist, for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC). The approval was based on the ARAMIS phase 3 trial (NCT02200614), which enrolled 1,509 patients with nonmetastatic CRPC and a prostate-specific antigen doubling time of 10 months or less. Patients were randomized in a 2:1 ratio to receive darolutamide or placebo along with continued androgen deprivation therapy for a primary end ...
Continue reading

Metastatic Melanoma: Dabrafenib/Trametinib Improves Outcomes

Historically, patients with metastatic melanoma have a poor prognosis. However, due to the development of BRAF- and MEK-targeted therapies, patient outcomes have improved. To further characterize the outcomes associated with these treatments, researchers compiled and analyzed data from two clinical trials and found that in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, dabrafenib plus trametinib had many long-term benefits in about one third of patients. D...
Continue reading

Copyright © 2021 Oncology Data Advisor. All rights reserved.