Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research &Development, LLC. “The results from the CANDOR study support the potential benefit of this DARZALEX-based combination regimen for patients with multiple myeloma who have relapsed from prior treatment.” Data from the Phase 3 CANDOR study were presented as a late-breaking abstract at the 2019 American Society of Hematology (ASH) Annual Meeting. About the CANDOR Study CANDOR is a randomized, open-label Phase 3 study of DARZALEX® (daratumumab), carfilzomib and dexamethasone (DKd) compared to carfilzomib and...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Consider COVID-19 in patients presenting with what looks like a typical cardiac syndrome, even in the absence of fever or cough, advise New York City-based cardiologists.Medscape Medical News
Source: Medscape Pathology Headlines - Category: Pathology Tags: Cardiology News Source Type: news
Conclusion. Over the 2-year follow-up period, PTED did not show superior clinical outcomes and did not appear to be safer procedure for patients with LDH compared with MED. PTED had inferior results for median disc herniation, whereas MED did not appear to be the best option for far-lateral disc herniation. Level of Evidence: 2
Source: Spine - Category: Orthopaedics Tags: RANDOMIZED TRIAL Source Type: research
Study Design. Cross-sectional. Objective. The aim of this study was to describe the self-experienced trunk appearance in individuals with and without idiopathic scoliosis. Summary of Background Data. Idiopathic scoliosis is the most common spinal deformity. A large scoliotic deformity increases the risk of back pain and pulmonary dysfunction. The deformity has also a psychological impact. Methods. The pictorial part of the spinal appearance questionnaire (pSAQ) was administered to 1416 individuals with idiopathic scoliosis (386 untreated, 529 brace treated, 501 surgically treated) and 272 individuals without sco...
Source: Spine - Category: Orthopaedics Tags: DEFORMITY Source Type: research
Conclusion. This study shows that financial worries were significantly associated with chronic spinal pain. Financial worries may be important to be taken into consideration by clinicians managing patients with spinal pain. More future research is needed to explore the association between financial worries and spinal pain. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: EPIDEMIOLOGY Source Type: research
Conclusion. The results of this study yield further support for the importance of rapid functional improvements during a PT episode of care. In addition, patients demonstrated roughly two-thirds of their improvement in the first 40% of visits regardless of their symptom duration. This study may help clinicians identify a need to modify a plan of care if insufficient early improvement is observed. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Study Design. Cross-cultural adaptation and psychometric evaluation. Objective. The aim of this study was to translate the Neck Disability Index (NDI) into the simplified-Chinese language and to evaluate the reliability, validity, and responsiveness of the new questionnaire. Summary of Background Data. Neck pain is a major health problem resulting in major disability. NDI is the most frequently used scale for self-rating of disability due to neck pain. At present, there is no simplified-Chinese version of the NDI. The aims of this study were to culturally adapt and translate the NDI into the simplified-Chinese lang...
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Study Design. A prospective cross-sectional study. Objective. To evaluate the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia and examine the variations in clinical parameters cause by this combination. Summary of Background Data. Although one of the many agents leading to lumbar pain is sacroiliac dysfunction, little progress has still been made to evaluate mechanical pain from sacroiliac joint dysfunction within the context of differential diagnosis of lumbar pain. Methods. Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in the study. Duri...
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Conclusions. The NPRS and GRCS were successfully adapted into Hausa language with acceptable reliability, validity, and responsiveness. These measures are appropriate for clinical and research use among Hausa-speaking patients. Level of Evidence: 2
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Conclusion. The mode of loading has an important impact on the severity and nature of failures seen in IVDs and the resulting consequences to biomechanics. However, further research is necessary to better understand to the mechanisms that link injury to degeneration and regeneration of IVD tissues. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: LITERATURE REVIEW Source Type: research
Study Design. Retrospective study. Objective. The purpose of the present study is to determine how body mass index (BMI) affects patient-reported outcome measurements (PROMs) after lumbar fusions. Summary of Background Data. Although greater preoperative BMI is known to increase the rates of adverse events after surgery, there is a paucity of literature assessing the influence of BMI on PROMs after lumbar fusion. Methods. Patients undergoing lumbar fusion surgery between 1 and 3 levels were retrospectively identified. PROMs analyzed were the Short Form-12 Physical Component Score, Mental Component Score, Oswestr...
Source: Spine - Category: Orthopaedics Tags: SURGERY Source Type: research
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