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Novel Therapy for Prostate Cancer Approved by FDA

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Neeraj Agarwal, MD, FASCO, Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, received approval by the U.S. Food and Drug Administration for a new prostate cancer treatment. This accomplishment comes shortly after he published the study in The Lancet, as the lead author, a first in institutional history.


The new treatment combines two cancer drugs, enzalutamide and talazoparib. While enzalutamide is a medication typically used for prostate cancer, the addition of talazoparib is new in patients with prostate cancer. In a phase 3 trial, this drug combination was found to decrease the risk of cancer progression by 55%, compared to the standard treatment in these patients for whom the FDA approved the combination.

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“Getting this therapy approved means improved outcomes for many people,” says Agarwal. “It is validation of our unwavering commitment to create and improve cancer treatments and to relieve the suffering of our patients.”


“This work, led by Dr. Agarwal, with colleagues across the world is absolutely groundbreaking,” says Neli Ulrich, PhD, chief scientific officer and executive director of the Comprehensive Cancer Center at Huntsman Cancer Institute. "It will make a big difference in treatment options for many prostate cancer patients.”


Prostate cancer is one of the most common cancers, according to the National Cancer Institute. It is also the second leading cause of cancer among men in the United States.


“Research at Huntsman Cancer Institute, led by Dr. Agarwal, has resulted in a major achievement in the treatment of patients with prostate cancer,” says Sachin Apte, MD, MS, MBA, chief clinical officer at Huntsman Cancer Institute. “This work demonstrates how the integration of clinical care and research directly translates into new treatment options for cancer patients.”


Agarwal is a dedicated researcher and clinician. As senior director for clinical research translation, he oversees many early and advanced-phase clinical trials.


Reference: Agarwal N, Azad AA, Carles J, et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. The Lancet. 2023;0(0). doi:10.1016/S0140-6736(23)01055-3



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