On June 13, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that data from its 1404 and PyLTM prostate cancer imaging programs will be presented at the upcoming Society of Nuclear Medicine and Molecular Imaging 2016 Annual Meeting, taking place from June 11 — 15, 2016 in San Diego, California (Press release, Progenics Pharmaceuticals, JUN 13, 2016, View Source [SID:1234513241]).

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The details of the presentations are included below.

1404 Tc-99m Diagnostic Imaging Agent

Title: SPECT/CT Imaging of Prostatic PSMA Expression with Tc99m trofolastat chloride in Healthy Volunteers
Date and Time: June 13th from 3:00 — 4:30 p.m. PT
Poster Number: 1546
Session: Meet the Author Poster Session I: Prostate/GU Posters

PyL F-18 Diagnostic Imaging Agent

Title: Normal Organ Uptake Variability on PSMA-Targeted 18F-DCFPyL PET/CT
Date and Time: June 14th at 4:54 p.m. PT
Poster Number: 519
Session: SS76: Prostate/GU: Prostate and Other Malignancies

Title: Application of 18F-labeled PSMA-imaging using [18F]DCFPyL at very low PSA-values may allow curative treatment in recurrent prostate cancer
Date and Time: June 15th at 8:24 a.m. PT
Poster Number: 561
Session: SS82: Prostate/GU: PSMA Imaging in Advanced Disease

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of >95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a clinical-stage, fluorinated PSMA-targeted PET imaging agent for prostate cancer that was discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. A proof-of-concept study published in the April 2015 issue of the Journal of Molecular Imaging and Biology demonstrated that PET imaging with PyL showed high levels of PyL uptake in sites of putative metastatic disease and primary tumors, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 180,890 new cases of prostate cancer will be diagnosed and about 26,120 men will die of the disease and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On June 13, 2016 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel E-selectin antagonist GMI-1271 for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and elderly patients aged 60 years or older with AML (Press release, GlycoMimetics, JUN 13, 2016, View Source [SID1234617424]).

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"We believe GMI-1271 has the potential to address important unmet needs for individuals with relapsed or refractory AML, as well as for older AML patients, for whom the standard of care often fails to provide outcomes as positive as those seen in other patient groups," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "The FDA’s granting of a Fast Track designation for GMI-1271 to treat AML is an important step in advancing this drug candidate through the regulatory process, and if successful, in bringing a novel drug to patients in an expedited time frame."

The Fast Track Designation is designed to facilitate development and expedite review of experimental therapies that address the unmet medical needs of patients with serious conditions.

AML is a cancer of immature white blood cells that starts in the bone marrow but can quickly spread into the blood, lymph nodes, liver, spleen, central nervous system, and testicles. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Chemotherapeutic methods among patients with refractory and relapsed AML have low remission rates, between 25 and 30 percent.

GlycoMimetics announced on Friday, June 10, presentation of data from the Phase 1 portion of its on-going Phase 1/ 2 clinical trial testing GMI-1271 combined with induction chemotherapy, in patients with relapsed/refractory acute myeloid leukemia (AML). Data was reported at the European Hematology Association (EHA) (Free EHA Whitepaper)21stCongress in Copenhagen, Denmark in a poster entitled "Results of a Phase 1 study of GMI-1271, a potent E-selectin antagonist in combination with induction chemotherapy in relapsed/refractory AML: a novel, well-tolerated regimen with a high remission rate."

In addition, GlycoMimetics recently announced that the first patient with relapsed or refractory AML has been dosed in the company’s Phase 2 portion of the ongoing Phase 1/2 clinical trial of GMI-1271. This clinical trial is a multinational open-label study evaluating endpoints for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in combination with induction chemotherapy in patients with high-risk AML. This trial is being conducted at a number of academic medical institutions in the United States, Ireland, and Australia. While the primary objective is to assess safety, additional endpoints include overall response rate, biomarkers of activity, durability of response and overall survival. The Phase 2 portion of the study is expected to include approximately 25 participants with relapsed or refractory AML and approximately 25 participants who are newly diagnosed.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

On June 13, 2016 Sunesis Pharmaceuticals (NASDAQ:SNSS) reported the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Press release, Sunesis, JUN 13, 2016, View Source;p=RssLanding&cat=news&id=2177015 [SID:1234513244]). The results were presented Saturday in an oral session titled "New Compounds in AML Treatment" at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. The presentation (abstract S505, Bella Center, Hall A3), titled "Phase I/ll study of vosaroxin and decitabine in newly diagnosed older patients with acute myeloid leukemia and high-risk myelodysplastic syndrome," is available at www.sunesis.com.

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"Older patients diagnosed with AML and MDS have limited treatment options and exceedingly poor outcomes," said Naval Daver, M.D., Assistant Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a study investigator. "At the optimized induction dose of 70 mg/m2 of vosaroxin, the combination of vosaroxin and decitabine demonstrates a compelling CR/CRp/CRi rate of 76% and a median overall survival of 16.1 months. This response rate and survival are significantly better than seen with single-agent decitabine among similar patients at our institution. This outcome was achieved with <5% induction mortality and good tolerability. In this vosaroxin-decitabine cohort, 23 of 41 patients remain alive."

Daniel Swisher, CEO of Sunesis, added: "We believe these results warrant further exploration in a larger outcome study, with plans currently under review to conduct a multicenter clinical trial comparing vosaroxin plus decitabine and vosaroxin plus cytarabine to the 7+3 regimen in patients with AML."

To date, 63 patients (56 AML, 7 high-risk MDS) with a median age of 69 years (range 60-78) have been enrolled in the trial. All 63 patients have completed at least 2 treatment rounds, rendering them evaluable for response; with a 75% overall response rate, 49% (31 patients) achieved complete remission (CR), 17% (11 patients) achieved CR with incomplete platelet recovery (CRp), and 8% (5 patients) achieved CR with incomplete peripheral blood count recovery (CRi). The therapy was well-tolerated, with the main therapy related grade 3 or higher toxicities being mucositis in 11 (17%) patients.

Initially for the first 22 patients in the study, the selected induction dose of vosaroxin was 90 mg/m2. Thereafter to reduce the incidence of mucositis, the induction dose was reduced to 70 mg/m2 for the next 41 patients. The lower dose of vosaroxin in combination with decitabine was associated with reduced early mortality and an improved overall response rate and OS, as follows:

Induction
Dose
(vosaroxin) N Median
OS 8-week
Mortality Overall
Response Need >1 Cycle to
Response
90 mg/m2 22 5.5 27 % 73 % 19 %
70 mg/m2 41 16.1 5 % 76 % 42 %

Sunesis also announced that follow-up data from the company’s VALOR trial was presented as an e-poster during the EHA (Free EHA Whitepaper) meeting. The poster (abstract E930, Bella Center, E-Poster Screens), titled "Characterization of patients with relapsed or refractory AML in continued follow-up after treatment with vosaroxin/cytarabine vs placebo/cytarabine in the VALOR trial," shows that, as of January 22, 2016, 83 of 711 patients enrolled in VALOR remain alive (46/356 in the vosaroxin/cytarabine arm, 37/355 in the placebo/cytarabine arm) and in follow up, which has reached a median of 40 months. In patients ≥60 years, more than twice as many patients were alive in the vosaroxin/cytarabine arm (23 vs. 10 patients).

All but seven patients in this follow up underwent allogeneic hematopoietic stem cell transplant (HCT). Of note, the non-HCT survivors were all in the vosaroxin/cytarabine treatment arm (68-71 years old, 2 primary refractory and 5 early relapsed).

Mr. Swisher added: "We are encouraged by the long-term benefit seen in the VALOR follow-up and also the potential for vosaroxin and cytarabine to provide long-term benefit in older patients who need more options."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On June 12, 2016 Pfizer Inc. today reported the publication of findings from the Phase 3 INO-VATE ALL study in the online issue of The New England Journal of Medicine (Press release, Pfizer, JUN 12, 2016, View Source [SID:1234513240]). The study, also known as Study 1022, is an open-label, randomized, Phase 3 study evaluating the safety and efficacy of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL). Results showed improvement over chemotherapy on a number of measures including complete hematologic remission and progression-free survival (PFS). Updated results and newly available overall survival (OS) data were also presented as a late-breaking oral presentation (#LB2233) today at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) 2016 Annual Meeting in Copenhagen, Denmark.

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"Relapsed or refractory ALL is an aggressive leukemia in urgent need of new treatment options as about half of adult patients will not respond to chemotherapy or will see their disease return," said Hagop M. Kantarjian, M. D., lead study investigator and professor, The University of Texas MD Anderson Cancer Center. "The efficacy results seen in patients treated with inotuzumab ozogamicin in this study are impressive, particularly median progression-free survival, high rates of hematological remission and absence of minimal residual disease. These results suggest inotuzumab ozogamicin, if approved, could be a valuable new addition to currently available treatment options for ALL patients, including as a bridge to stem cell transplantation, which is the best chance for a cure at this stage of the disease."

The INO-VATE ALL study had two independent primary endpoints, complete response with or without hematologic remission and OS. INO-VATE ALL met its first primary endpoint of complete response, which was significantly better with inotuzumab ozogamicin compared to chemotherapy (80.7% [95% CI, 72%-88%] vs. 29.4% [95% CI, 21%-39%], P<0.001). Inotuzumab ozogamicin also significantly extended PFS compared to chemotherapy (HR: 0.45 [97.5% CI, 0.34-0.61], P<0.001; median PFS, 5.0 vs. 1.8 months, in their respective arms). The second primary endpoint of OS showed a strong trend toward longer OS for patients treated with inotuzumab ozogamicin compared to chemotherapy, but did not reach the level of statistical significance (p < 0.0104) for the trial (HR: 0.77 [97.5% CI, 0.58-1.03], one-sided P=0.0203; median OS, 7.7 months [95% CI, 6.0-9.2] vs. 6.7 months [95% CI, 4.9-8.3]). The two-year OS rate for inotuzumab ozogamicin was 23 percent (95% CI, 16%‒30%) compared to chemotherapy at 10 percent (95% CI, 5%‒16%).

"Adult patients with relapsed or refractory ALL have a five-year survival rate of less than 10 percent, making these patients particularly difficult to treat. To see remission rates and two-year survival rates that are more than doubled compared to standard of care chemotherapy is very gratifying. We believe these data add to the growing body of evidence that supports inotuzumab ozogamicin as an important potential treatment option in adults with relapsed or refractory ALL," said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.

Results from INO-VATE ALL also showed patients treated with inotuzumab ozogamicin achieved high rates of minimal residual disease (MRD) negativity (78.4% [95% CI, 68%-87%; P<0.001]), and experienced a duration of response (DOR) of 4.6 months (95% CI, 3.9-5.4; HR: 0.55; P<0.034). In comparison, 28.1 percent (95% CI, 14%-47%; P<0.001) of patients treated with chemotherapy achieved MRD negativity and median DOR was 3.1 months (95% CI, 1.4-4.9; HR: 0.55; P<0.034). More patients also proceeded to stem-cell transplant with inotuzumab ozogamicin compared to standard chemotherapy (41% vs. 11%, P<0.001).

The most common adverse events (AEs) observed for both inotuzumab ozogamicin and chemotherapy were cytopenias, including febrile neutropenia (16% vs. 22%). Common nonhematologic treatment-emergent AEs with inotuzumab ozogamicin included nausea (32%), headache (28%) and pyrexia (27%). Patients in the chemotherapy arm experienced nausea (47%), pyrexia (43%) and diarrhea (40%).

Additionally, any-grade veno-occlusive liver disease (VOD) occurred more frequently in patients treated with inotuzumab ozogamicin compared to chemotherapy (11% vs. 1%). Five patients taking inotuzumab ozogamicin developed VOD during treatment and 10 patients developed VOD after subsequent stem cell transplant. Among those taking chemotherapy, one patient developed VOD after transplant; no cases of VOD occurred during treatment with chemotherapy.

Inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for ALL in October 2015. Pfizer is working closely with the FDA and other regulatory authorities with the aim of making inotuzumab ozogamicin available for adult patients with relapsed or refractory CD22-positive ALL.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.1 The current foundational treatment is intensive, long-term chemotherapy.2 In 2016, it is estimated that 6,590 cases of ALL will be diagnosed in the United States, with about 2 in 5 cases in adults.3 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.4 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.5

About Inotuzumab Ozogamicin

Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen found on cancer cells in almost all B-ALL patients, linked to a cytotoxic agent. 1,6 When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is thought to be internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.7

Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.

On June 11, 2016 Janssen-Cilag International NV reported results from the international Phase 3, randomised, double-blind, placebo-controlled, multicentre study, EPOANE 3021 (Press release, Janssen-Cilag International, JUN 11, 2016, View Source [SID:1234513282]).The study demonstrated the efficacy and safety of EPREX (epoetin alfa) as a treatment for anaemia, in adult patients with low or intermediate-1 risk myelodysplastic syndromes (MDS), as classified by an International Prognostic Scoring System (IPSS).1 EPOANE 3021 data were presented at the 21st Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Abstract P248).

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These data, along with three registry studies from across Europe, have been submitted to the French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), as the reference health authority for EPREX (epoetin alfa) within the mutual recognition procedure, to extend the existing marketing authorisation in Europe. A decision is expected in the coming months.

EPOANE 3021 was designed to evaluate whether epoetin alfa improves anaemia in patients with MDS, versus placebo over 24-weeks of treatment. It consisted of 130 randomised patients, with 85 patients receiving epoetin alfa. Results showed that compared to placebo, patients in the epoetin alfa arm demonstrated a statistically significantly higher erythroid response rate (according to IWG2006 criteria) in the first 24 weeks, the primary endpoint of the study (31.8 percent vs. 4.4 percent, p<0.001). Significantly fewer patients required transfusion on epoetin alfa (24.7 percent vs. 54.1 percent).1 Additional analysis, accounting for dose adjustments within the protocol, also confirmed a statistically significant erythroid response for epoetin alfa (45.9 percent) compared to placebo (4.4 percent) (p<0.001).1 Quality of life for responding patients in the epoetin alfa arm improved significantly compared to non-responders (FACT-An p=0.025, EQ-5D index score p=0.007, EQ-5D VAS p=0.037). There were no new safety signals for epoetin alfa from the study and safety findings were consistent with the known safety profile of epoetin alfa.1

"Anaemia affects the vast majority of patients with MDS and contributes substantially to their symptoms. However, there are currently no approved erythropoiesis stimulating agents approved for treating anaemia in lower-risk MDS patients," said Pierre Fenaux, M.D., PhD., principal investigator of EPOANE 3021, and Professor of Hematology, Hôpital St Louis/Université, Paris, France. "These data provide important evidence that epoetin alfa can effectively manage lower risk MDS-related anaemia, beyond transfusion, and without any impact on progression to acute myeloid leukaemia (AML)."

"EPREX (epoetin alfa) has shown great potential across a range of indications throughout its clinical development programme. We are excited to be building on this evidence base once again, with the findings of this new study demonstrating the meaningful difference this medicine can make to patients with MDS-related anaemia. We’re also extremely pleased to see the improvements in quality of life offered by EPREX, where alternative treatment options have so far been limited," said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa.

For more information on the EPOANE 3021 data presented at EHA (Free EHA Whitepaper) 2016, please view the abstract online.

About the EPOANE 3021 Study1

EPOANE 3021 was a randomised, double-blind, placebo-controlled, multicentre clinical trial investigating the efficacy and safety of EPREX (epoetin alfa) as a treatment for anaemia, in adult patients with low or Intermediate-1 risk myelodysplastic syndromes (MDS), as classified by an International Prognostic Scoring System (IPSS). Results demonstrated that 31.8 percent of patients treated with epoetin alfa achieved the primary endpoint of erythroid response versus 4.4 percent of placebo patients (p<0.001). An ad hoc analysis, accounting for the dose adjustments as per the protocol, confirmed a statistically significant erythroid response for epoetin alfa, with 45.9 percent of epoetin alfa patients, versus 4.4 percent of placebo patients achieving an erythroid response (p<0.001). Median erythroid response duration for epoetin alfa patients was 197 days. The number of patients needing transfusion in the epoetin alfa arm steadily decreased from 51.8 percent in the 8 weeks prior to baseline, to 24.7 percent by week-24. Transfusion need remained unchanged in the placebo patients (48.9 percent – 54.1 percent) over the same interval. Time to first transfusion was longer in the epoetin alfa group (p=0.046). Epoetin alfa demonstrated a statistically significant improvement of quality of life in responding patients.

There were no new safety signals for epoetin alfa from the study and safety findings are consistent with the known safety profile of epoetin alfa. The proportion of patients with at least one treatment emergent adverse event (TEAE) was numerically higher in the placebo group compared with the epoetin alfa group (88.9 percent vs. 77.6 percent). Drug discontinuation due to adverse events was 10.6 percent in the epoetin alfa group versus 13.3 percent in placebo. Four patients in the epoetin alfa arm (4.7 percent) and none in placebo reported a thrombovascular event (TVE). There were four fatal outcomes in the epoetin alfa arm versus one in the placebo arm; none were reported to be related to the study drug. During the study, progression to acute myeloid leukaemia (AML) was similar between groups (3.5 percent in epoetin alfa; 4.4 percent in placebo).

About Myelodysplastic Syndromes (MDS)

Myelodysplastic syndromes (MDS) are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells.2 The low numbers of normal blood cells (cytopenias) eventually cause symptoms, including infection, anaemia, spontaneous bleeding, or easy bruising.2,3 The natural course of MDS is highly variable, with overall survival ranging from a few weeks to several years.4 MDS is primarily a disease of the elderly with a median age at diagnosis of 70 years, but it can affect younger patients as well.4 The incidence in Europe is about four cases per 100,000 per year, reaching 40-50 per 100,000 in patients aged 70 years and over.4

Approximately 60-80 percent of patients with MDS experience symptomatic anaemia,5 which can significantly reduce quality of life and often requires repeated blood transfusions.2 Controlling anaemia and improving quality of life are the principal aims of treatment in lower risk MDS patients.4 At present, blood transfusions are currently the only approved treatment option; however these lead to iron overload, which is associated with significant morbidity and mortality.4,5

About EPREX (epoetin alfa)

EPREX (epoetin alfa) is an erythreopoiesis-stimulating agent (ESA) that works by stimulating the production of red blood cells (RBCs).6 ESAs are an important treatment option for patients with certain types of anaemia, including chemotherapy-induced anaemia and anaemia due to chronic kidney disease. Without ESAs, patients with certain types of anaemia may require regular blood transfusions to maintain RBCs at concentrations necessary to sustain normal oxygen levels throughout the body.4

EPREX is currently indicated for the treatment of:6

Symptomatic anaemia associated with chronic renal failure (CRF):
In adult and paediatric patients aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis.
In adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients.
Adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin concentration range between 10 to 13 g/dl [6.2 to 8.1 mmol/l], no iron deficiency) if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml).
About the Janssen Pharmaceutical Companies