U.S. FDA Approves IMBRUVICA ® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

HORSHAM, Pa., April 21, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s milestone marks the 11th U.S. FDA approval for IMBRUVICA® across six disease areas and is the sixth approval for IMBRUVICA® in CLL.The E1912 study showed newly diagnosed patients ages 70 years or younger (median age of 58 years) treated with IMBRUVICA® plus rituximab lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent at 37 months, compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR), with a PFS rate of 75 percent. Extended follow-up results from the E1912 study were most recently presented at the 2019 American Society of Hematology (ASH) Annual Meeting. “FCR, a chemoimmunotherapy-based regimen, has been the standard of care for many previously untreated younger patients with CLL. With the introduction of this ibrutinib-rituximab combination, patients now have a mor...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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This article is licensed under aCreative Commons Attribution-NonCommercial 3.0 Unported Licence.Bjoern C Froehlich, Robert Popp, Constance A Sobsey, Sahar Ibrahim, Andre M LeBlanc, Yassene Mohammed, Marguerite Buchanan, Adriana Aguilar-Mahecha, Oliver Poetz, Michael X Chen, Alan Spatz, Mark Basik, Gerald Batist, Rene Zahedi, Christoph H. Borchers The PI3-kinase/AKT/mTOR pathway plays a central role in cancer signaling. While p110 α is the catalytic α-subunit of PI3-kinase and a major drug target, PTEN is the main negative regulator of... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Analyst latest articles - Category: Chemistry Authors: Source Type: research
CASES: Two patients presented with medial chest pain and deformity after high-speed motor vehicle accidents (MVAs) in which they were restrained drivers. Physical examination revealed retraction of the pectoralis major from the sternum on resisted adductio...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Fascinating but unfortunate case: Carotid Blowout Syndrome [Oncology] Patient in late 40s diagnosed with SCC. Surgical resection incomplete due to bleeding complications (not communicated well). Pt receives 60Gy over 30 treatment days. Patient ultimately dies of carotid blowout syndrome. Sues the hospital, asks for>30 million to settle the case. Patient was highly-paid insurance executive. Exact settlement is confidential but likely was in the low 8 figure range.
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Radiation Oncology Source Type: forums
I'm taking care of an outpatient patient: 60y/o woman with chronic abdominal pain with prior history of gastric bypass, appendectomy, incisional hernia repair. Her pain had been previously controlled with oxycodone 10mg a couple times a day, but recently less effective due to emesis. GI is following now, has her on Zofran, Reglan, Promethazine but the nausea is still pretty severe. Patient is cachectic and having trouble with PO intake. Utox is appropriate. I'm considering a Fentanyl patch... Read more
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
NEW YORK (Reuters Health)—Lower doses of cannabidiol (CBD) failed to provide any meaningful reduction in pain when added to other analgesic therapy in patients with hand osteoarthritis (OA) or psoriatic arthritis (PsA) in a randomized, placebo-controlled study from Denmark.1 Writing in the journal, Pain, Jonathan Vela, MD, and colleagues of Aalborg University note that CBD... [Read More]
Source: The Rheumatologist - Category: Rheumatology Authors: Tags: Analgesics Drug Updates cannabidiol (CBD) hand osteoarthritis hand pain PsA Psoriatic Arthritis Source Type: research
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The White House announced Monday that visitors will be required to show proof of vaccination and a negative COVID-19 test taken within three days of departure.WebMD Health News
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ConclusionsThis systematic review suggests that women with HPV- and p16-positive vaginal cancer have an improved prognosis compared with those with HPV- or p16-negative vaginal cancer. Results for p53 were varied, and no conclusion could be reached. Only 12 studies could be included in the review, of which most were based on small populations. Hence, further and larger studies on the prognostic impact of HPV, p16, and p53 in vaginal cancer are warranted.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: SYSTEMATIC REVIEW Source Type: research
A correction to this paper has been published: https://doi.org/10.1007/s00228-021-03165-2
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
ConclusionsThe present analysis suggests that fondaparinux is safer than UFH in the management of OHCA due to AMI by reducing early bleeding complications at one month.
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
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