Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.
The FDA has approved a supplemental new drug application (sNDA) for Bayer’s Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubequa is oral an androgen receptor inhibitor that is also approved to treat non-metastatic castration-resistant prostate cancer.
“This new indication for NUBEQA Nubeqa is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients,” Matthew Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, said in a press release.
The approval was made under the FDA’s Real-Time Oncology Review (RTOR) pilot program based on results of the phase 3 ARASENS trial. Results demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint, with a reduction in the risk of death by 32% for those treated with Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel. Treatment with Nubeqa plus androgen deprivation therapy and docetaxel also resulted in a statistically significant delay in time to pain progression.
The ARASENS results were presented earlier this year at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.
Incidence of adverse reactions was similar between both study arms. Adverse reactions reported for Nubeqa with docetaxel above 10% were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. Serious adverse reactions occurred in 45% of patients receiving Nubeqa and in 42% of patients receiving placebo. Fatal adverse reactions occurred in 4% of patients receiving Nubeqa and in 4% of patients receiving placebo.
Nubeqa is being investigated other studies across various stages of prostate cancer.
FDA Sets Goal Date for Lymphoma Drug Columvi
December 5th 2024The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.
Read More
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen