XARELTO® Associated With a Decreased Risk of Recurrent VTE

MedicalResearch.com Interview with:

Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC.

Dr. Burton

Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Internal Medicine
Janssen Scientific Affairs, LLC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: More than 900,000 Americans experience a venous thromboembolism (VTE) each year, with about one-third of these occurrences being fatal. Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a Factor Xa inhibitor, like XARELTO® (rivaroxaban), for three months or longer. For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years.

This study examined extended use of XARELTO® after the recommended three-month treatment period in patients who experienced an initial VTE, showing XARELTO® was associated with a decreased risk of recurrent VTE with no increase in major bleeding during this time period.  Continue reading

Healthcare Costs in Patients with Cancer Rise with Increasing Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC.

Dr. Burton

Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Internal Medicine
Janssen Scientific Affairs, LLC.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Despite being largely preventable, venous thromboembolism (VTE) is the second leading cause of death in people with cancer. The risk of VTE is five times greater in people with cancer than those without cancer, and that risk is magnified in those receiving certain types of chemotherapy, in the newly diagnosed and in those with more advanced, metastatic disease. This 6,194-patient study examined economic burden associated with VTE, and found patients newly diagnosed with cancer who are at a higher risk of a VTE had significantly higher all-cause and VTE-related health care costs compared to patients with a lower risk of VTE. Continue reading

Alcyone Trial: DaraVMP New Standard for Transplant-Ineligible Newly Diagnosed Multiple Myeloma

MedicalResearch.com Interview with:

Maria-Victoria Mateos, MD, PhD Associate Professor of Medicine  University of Salamanca Salamanca, Spain

Dr. Mateos

Maria-Victoria Mateos, MD, PhD
Associate Professor of Medicine
University of Salamanca
Salamanca, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Alcyone trial is a phase 3 trial in which Daratumumab, the CD38 mAb has been added to a standard of care for elderly newly diagnosed myeloma patients, VMP, and compared with VMP. The main finding is that the addition of dara to VMP resulted into a significant benefit in PFS with a 57% reduction in the risk of progression and/or death. In addition, the benefit was also reported in terms of ORR and CR rate and 45% of patients receiving Dara VMP achieved CR. Minimal residual disease was evaluated and was undetectable in 27% of the patients what it is relevant because a 5% increase was observed in comparison with the publication one year ago. This means that Daratumumab as maintenance after the first 9 cycles daraVMP was able to upgrade the quality of response. Toxicity profile was acceptable and no new safety signals were reported. Continue reading

CLL: Overall Treatment Savings With Ibrutinib (Imbruvica) Despite Higher Prescription Costs

MedicalResearch.com Interview with:

Dr. Sundaram

Murali Sundaram, MBA, Ph.D.
Director of Real World Value and Evidence
Oncology, Janssen

MedicalResearch.com: What is the background for this study?

Response: Ibrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor approved for the treatment of patients with newly diagnosed chronic lymphocytic leukemia (CLL).

Ibrutinib is administered orally while standard of care (CD20 monoclonal antibody-based chemoimmunotherapy [CIT]) is administered intravenously. This difference in route of administration impacts what type of benefit covers these treatments (i.e., pharmacy benefit for oral ibrutinib and medical benefit for intravenous CIT).

Previous studies evaluating the costs burden of patients treated with ibrutinib versus CIT did not include the full spectrum of real-world healthcare costs.

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ZYTIGA May Benefit Newly Diagnosed High-Risk Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Craig Tendler, M.D. Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care Janssen Research & Development, LLC.

Dr. Tendler

Craig Tendler, M.D.
Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care
Janssen Research & Development, LLC. 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Janssen announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of ZYTIGA in combination with prednisone and androgen deprivation therapy (ADT) to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).

This submission is based on the pivotal Phase 3 LATITUDE trial results presented earlier this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting, which found that in patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHNPC), abiraterone acetate with prednisone in combination with androgen deprivation therapy (ADT) demonstrated a significant improvement in median overall survival (OS) and in radiographic progression-free survival (rPFS). Additional data, which were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference, demonstrated clinically meaningful and statistically significant improvements in patient reported outcomes (PRO) in patients with high-risk mHNPC who received ZYTIGA in combination with prednisone and ADT compared to placebo plus ADT alone.
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