SEAL BEACH, Calif.--(BUSINESS WIRE)--Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, today announced that data on long-term clinical outcomes and health economics and outcomes research (HEOR) related to sipuleucel-T (PROVENGE®) will be presented at the American Urological Association Annual Meeting, taking place May 3-6, 2019 in Chicago.
“Sipuleucel-T has consistently demonstrated a survival benefit in both controlled clinical trials and real-world settings,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “These data offer compelling evidence that sipuleucel-T is a cost-effective option, and should be used as first line therapy prior to oral oncolytics in patients with advanced prostate cancer.”
Details of the two presentations, including a podium session and moderated poster respectively, follow:
Characterization of long-term survivors from PROCEED, a registry of sipuleucel-T in metastatic castration-resistant prostate cancer (MCRPC)
|Presenter:||Lawrence I. Karsh, M.D., FACS, Attending Urologist and Director, Clinical Research Department, The Urology Center of Colorado (TUCC), Denver|
|Podium Session:||PD25: Prostate Cancer: Advanced (including Drug Therapy) III|
|Date and Time:||Saturday, May 4, 10:20-10:30 a.m. CT|
|Location:||McCormick Place: W185d|
Indirect comparison of survival and cost per number needed to treat to benefit analysis of abiraterone, enzalutamide, and sipuleucel-T in the treatment of metastatic castration-resistant prostate cancer
|Presenter:||David S. Morris, M.D., FACS, Urologist, Urology Associates, Nashville, Tenn.|
|Moderated Poster:||MP22: Prostate Cancer: Advanced (including Drug Therapy) II|
|Date and Time:||Saturday, May 4, 7:00-9:00 a.m. CT|
|Location:||McCormick Place: W179a|
About PROVENGE® (sipuleucel-T)
PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for men in the advanced stages of the disease.
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.
Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.
Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.
Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.
Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.
Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
For full Prescribing Information, please visit www.dendreon.com/Products.
Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy. Dendreon’s flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient’s own immune cells. More than 30,000 men with advanced prostate cancer have been prescribed PROVENGE in the U.S. since 2010. Dendreon also is evaluating the use of PROVENGE in early-stage prostate cancer, with the hope of curing more men of the disease. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit www.dendreon.com.