THOUSAND OAKS, Calif., May 13, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that data at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) will showcase the Company’s continued efforts across both pipeline and marketed products, including key results in the treatment of solid tumors and hematologic malignancies.
“The data at ASCO reflect our significant progress in developing treatments across our oncology pipeline and portfolio,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Our focus is to address unmet needs for patients by translating innovation in research into much-needed therapeutic options.”
Key data include new findings from clinical trials in multiple myeloma, breast cancer, metastatic melanoma, acute lymphoblastic leukemia (ALL) and metastatic colorectal cancer (mCRC).
Latest Research in Hematologic Malignancies:
Kyprolis ® (carfilzomib) for Injection
In multiple myeloma, full results are being presented from the Phase 3 head-to-head ENDEAVOR trial evaluating Kyprolis compared to Velcade® (bortezomib), as well as results from the Phase 1/2 CHAMPION-1 study and a secondary analysis from the pivotal Phase 3 ASPIRE study.
- Carfilzomib and dexamethasone vs. bortezomib and dexamethasone in patients with relapsed multiple myeloma: results from the Phase 3 study ENDEAVOR
Abstract No. 8509, Lymphoma and Plasma Cell Disorders Oral Abstract Session, Tuesday, June 2, 9:45 a.m. to 12:45 p.m. CT (Presentation Time: 9:57 a.m. to 10:09 a.m. CT), E354b - Updated results from CHAMPION-1, a Phase 1/2 study investigating weekly carfilzomib with dexamethasone for patients with relapsed or refractory multiple myeloma
Abstract No. 8527, Lymphoma and Plasma Cell Disorders Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A - Effect of carfilzomib, lenalidomide, and dexamethasone vs. lenalidomide and dexamethasone in patients with relapsed multiple myeloma by line of therapy: secondary analysis from an interim analysis of the Phase 3 study ASPIRE
Abstract No. 8525, Lymphoma and Plasma Cell Disorders Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A
BLINCYTO® (blinatumomab)
BLINCYTO data at ASCO will focus on targeted patient populations within adult relapsed/refractory ALL to better understand response to treatment.
- Re-exposure to blinatumomab after CD19-positive relapse: Experience from three trials in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia
Abstract No. 7051, Leukemia, Myelodysplasia, and Transplantation Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A - Safety and activity of blinatumomab for older patients with relapsed/refractory B-precursor acute lymphoblastic leukemia in two Phase 2 studies
Abstract No. 7043, Leukemia, Myelodysplasia, and Transplantation Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A - Factors influencing outcomes in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia treated with blinatumomab in a Phase 2 study
Abstract No. 7057, Leukemia, Myelodysplasia, and Transplantation Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A - Pharmacokinetics/pharmacodynamics of blinatumomab in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia
Abstract No. 2561, Developmental Therapeutics Poster Session, Saturday, May 30, 8 a.m. to 11:30 a.m. CT, S Hall A
Key Data in Solid Tumors and Supportive Care:
Prolia® (denosumab)
Results will be featured from a Phase 3 study evaluating the effects of denosumab compared with placebo on time to first clinical fracture in postmenopausal patients with hormone receptor positive breast cancer receiving aromatase inhibitor (AI) treatment.
- Adjuvant denosumab in breast cancer: results from 3,425 postmenopausal patients of the ABCSG-18 trial
Abstract No. 504, Breast Cancer Oral Abstract Session, Monday, June 1, 8 a.m. to 11 a.m. CT (Presentation Time: 9:12 a.m. to 9:24 a.m. CT), N Hall B1
Talimogene Laherparepvec
New talimogene laherparepvec data will be presented from combination studies with checkpoint inhibitors (anti-PD1 and anti-CTLA4), a neoadjuvant trial in progress, and additional analyses from the pivotal Phase 3 OPTiM study in patients with metastatic melanoma.
- Survival, safety, and response patterns in a Phase 1b multicenter trial of talimogene laherparepvec and ipilimumab in previously untreated, unresected stage IIIB-IV melanoma
Abstract No. 9063, Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A - Tumor size and clinical outcomes in melanoma patients treated with talimogene laherparepvec
Abstract No. 9074, Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A - A multicenter, open-label trial of talimogene laherparepvec plus pembrolizumab vs. pembrolizumab monotherapy in previously untreated, unresected, stage IIIB-IV melanoma (Trials in Progress abstract)
Abstract No. TPS9081, Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A - Phase 2, multicenter, randomized, open-label trial assessing efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery vs. surgery for resectable Stage IIIB/C and IVM1a melanoma (Trials in Progress abstract)
Abstract No. TPS9094, Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A
Vectibix® (panitumumab)
In addition to final results from the Phase 3 ASPECCT study, which investigates Vectibix compared to cetuximab in wild-type KRAS mCRC, results from the Phase 2 PEAK study, the Phase 3 PRIME trial and the Phase 2 ‘314 study, which examines expression of amphiregulin and response to first-line Vectibix plus FOLFIRI, will be presented.
- Final results from ASPECCT: Randomized Phase 3 non-inferiority study of panitumumab vs. cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer
Abstract No. 3586, Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A - Randomized Phase 3 study of panitumumab vs. cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer: outcomes by hypomagnesemia in ASPECCT
Abstract No. 3587, Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A - Tumor response outcomes in first-line treatment of wild-type RAS metastatic colorectal carcinoma following modified FOLFOX6 + either panitumumab or bevacizumab
Abstract No. 3535, Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A - The PRIME trial: Quality-adjusted survival in patients with RAS wild-type metastatic colorectal cancer receiving first-line therapy with panitumumab plus FOLFOX vs. FOLFOX alone
Abstract No. 3543, Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A - Expression of amphiregulin and response to first-line panitumumab + FOLFIRI in metastatic colorectal cancer
Abstract No. 3536, Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A
Neulasta® (pegfilgrastim)
Results from three studies evaluating the impact of administration and the risk of febrile neutropenia following myelosuppresive chemotherapy administration will be published.
- Risk of febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy and pegfilgrastim prophylaxis: does day of administration matter? (Publication Only abstract)
- Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in U.S. clinical practice (Publication Only abstract)
- Effect of timing of pegfilgrastim administration on absolute neutrophil count trajectory among cancer patients receiving myelosuppressive chemotherapy (Publication Only abstract)
XGEVA® (denosumab)
An ongoing head-to-head clinical trial investigating XGEVA compared to zoledronic acid in patients with multiple myeloma will be presented (study 20090482).
- Denosumab compared with zoledronic acid for the treatment of bone disease in adults with newly diagnosed multiple myeloma; An international, randomized, double-blind trial (Trial in Progress Abstract)
Abstract No. TPS8611, Lymphoma and Plasma Cell Disorders Poster Session, Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A
Amgen Post-ASCO Summary Webcast
Amgen will hold a post-ASCO summary webcast on Tuesday, June 2 at 1 p.m. CT. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators will participate to discuss data presented at ASCO and Amgen’s broader oncology portfolio of products.
Live audio of the event will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the U.S. FDA granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel and Mexico. For more information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
This safety information is specific to the current U.S. approved indication, which is based on Phase 2 studies.
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events (5 patients), end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity, thrombotic thrombocytopenic purpura / hemolytic uremic syndrome (TTP/HUS), posterior reversible encephalopathy syndrome (PRES), and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2 percent of patients treated with Kyprolis and was Grade 3 or greater in less than 1 percent of patients. Dyspnea was reported in 35 percent of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5 percent; no Grade 4 events and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in <1 percent of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1 percent of patients and discontinuation of treatment with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been reported (<1 percent). Kyprolis can cause elevations of serum transaminases and bilirubin.
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) including fatal outcome have been reported in patients who received KYPROLIS.
PRES, formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a neurological disorder, which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging (MRI). Cases of PRES have been reported in patients receiving KYPROLIS.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia and congestive heart failure. The most common adverse reactions (incidence of 30 percent or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and pyrexia. Serious adverse reactions were reported in 45 percent of patients.
Full prescribing information is available at www.kyprolis.com.
About BLINCYTO® (blinatumomab)
BLINCYTO is first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Prior to approval, BLINCYTO was granted breakthrough therapy and priority review designation by the FDA.
Important U.S. Product Information
BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
- Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
- Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
Contraindications
BLINCYTO is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO as outlined in the Prescribing Information (PI).
- Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO as outlined in the PI.
- Infections: Approximately 25% of patients receiving BLINCYTO experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO as needed.
- Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO as needed to manage these events.
- Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters during BLINCYTO infusion and interrupt BLINCYTO if prolonged neutropenia occurs.
- Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
- Elevated Liver Enzymes: Transient elevations in liver enzymes are associated with BLINCYTO® treatment. The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO® treatment. BLINCYTO treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
- Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and anti-leukemic chemotherapy.
- Preparation and administration errors have occurred. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
Adverse Events
The most commonly reported adverse reactions (> 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
Dosage and Administration Guidelines
- BLINCYTO is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
- It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
Please see full Prescribing Information and medication guide for BLINCYTO® at www.BLINCYTO.com.
About Prolia® (denosumab)
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts).
Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is also approved for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
Prolia is approved in the EU plus Switzerland, Norway, Iceland and Liechtenstein for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Prolia is also approved in the EU for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
Prolia is administered as a single subcutaneous injection of 60 mg once every six months. Please see the Important Saftey Information below.
Important Safety Information (U.S.)
Prolia is contraindicated in patients with hypocalcemia. Preexisting hypocalcemia must be corrected prior to initiating Prolia. Prolia is contraindicated in women who are pregnant and may cause fetal harm. Prolia is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria. Prolia contains the same active ingredient (denosumab) found in XGEVA®. Patients receiving Prolia should not receive XGEVA.
Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia. Hypocalcemia may worsen in patients taking Prolia, especially in patients with severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia injection. Adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving Prolia. A routine oral exam should be performed by the prescriber prior to initiation of Prolia. A dental examination with appropriate preventive dentistry is recommended prior to treatment with Prolia in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. Good oral hygiene practices should be maintained during treatment. For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Prolia therapy should be considered based on individual benefit-risk assessment.
Atypical low-energy or low trauma fractures of the shaft have been reported in patients receiving Prolia. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents. During Prolia treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of Prolia therapy should be considered, pending a risk/benefit assessment, on an individual basis.
In a clinical trial (N= 7800) in women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the Prolia group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear were more frequent in patients treated with Prolia. Endocarditis was also reported more frequently in Prolia-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on Prolia, prescribers should assess the need for continued Prolia therapy.
In the same clinical trial in women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing Prolia if severe symptoms develop.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia. Consider discontinuing use if severe symptoms develop. Suppression of Bone Turnover In clinical trials in women with postmenopausal osteoporosis, Prolia resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment are unknown. Monitor patients for these consequences, including ONJ, atypical fractures, and delayed fracture healing.
It is not known whether Prolia is excreted into human milk. Measurable concentrations of denosumab were present in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab ( 0.5% milk:serum ratio). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Prolia®, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The most common adverse reactions (>5% and more common than placebo) in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions (> 5% and more common than placebo) in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with Prolia. In women with postmenopausal osteoporosis, the overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia groups. In men with osteoporosis, new malignancies were reported in no patients in the placebo group and 4 (3.3%) patients in the Prolia group. A causal relationship to drug exposure has not been established. Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity. The most common (per patient incidence 10%) adverse reactions reported with Prolia in patients with bone loss receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. Additionally, in Proliatreated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
For more information, please see the Prolia Important Safety Information, Prescribing Information, and Medication Guide.
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