{"id":510155,"date":"2021-07-07T07:48:19","date_gmt":"2021-07-07T11:48:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-approves-vyxeos-the-first-chemotherapy-advance-in-over-40-years-for-adults-with-high-risk-acute-myeloid-leukemia-aml\/"},"modified":"2021-07-07T07:48:19","modified_gmt":"2021-07-07T11:48:19","slug":"health-canada-approves-vyxeos-the-first-chemotherapy-advance-in-over-40-years-for-adults-with-high-risk-acute-myeloid-leukemia-aml","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-approves-vyxeos-the-first-chemotherapy-advance-in-over-40-years-for-adults-with-high-risk-acute-myeloid-leukemia-aml\/","title":{"rendered":"Health Canada Approves Vyxeos\u00ae, the First Chemotherapy Advance in over 40 years for Adults with High-risk Acute Myeloid Leukemia (AML)"},"content":{"rendered":"
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Canada NewsWire<\/p>\n<\/p><\/div>\n

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\n DUBLIN<\/span>
\n <\/span>, July 7, 2021<\/span><\/span> \/CNW\/ – Jazz Pharmaceuticals plc (NASDAQ: JAZZ) today announced the Health Canada approval and availability of Vyxeos\u00ae<\/sup>\u00a0(daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).1<\/sup><\/p>\n

AML, a cancer of the bone marrow and the blood, progresses rapidly without treatment.2 <\/sup>Specifically, high-risk AML includes t-AML and AML-MRC.3<\/sup> T-AML is caused by previous therapeutic treatments while AML-MRC occurs when there are certain changes in the bone marrow, which is the spongy tissue inside the bones.1<\/sup>\u00a0<\/p>\n

Considered a rare disease, AML affects approximately 1,100 men and women in Canada<\/span> annually.4<\/sup>\u00a0 Though the number of AML cases has continued to rise5<\/sup>, the current treatment regimen for patients with high-risk AML has remained the same for decades until now.6\u00a0<\/sup><\/p>\n

“Vyxeos<\/i>\u00a0is not only an effective treatment option but a significant advance by providing this patient population with a chemotherapy agent that takes less time to administer and provides a better chance at survival than our standard current treatment for high-risk AML,” said Dr. Brian Leber<\/span>, clinical hematologist, Juravinski Cancer Centre, Hamilton Health Sciences in Hamilton<\/span>, Ontario.\u00a0“Having more time is a substantial win for these patients and their families.”<\/p>\n

The approval of Vyxeos<\/i>\u00a0is based on results from a Phase 3 study of 309 adult\u00a0patients, aged 60-75, with newly diagnosed t-AML or AML-MRC.1<\/sup>\u00a0The study met its primary endpoint as Vyxeos<\/i> demonstrated a superior improvement in overall survival compared to the current conventional treatment group.1<\/sup> The median overall survival for the Vyxeos<\/i> treatment group was 9.6 months compared with 6.0 months for the current conventional treatment\u00a0group.1<\/sup><\/p>\n

The most common adverse reactions (\u2265 10% Incidence) attributed to Vyxeos <\/i>are infection, febrile neutropenia, rash, transfusion reactions, sleep disorders, anxiety, delirium, headache, dizziness, visual impairment, non-conduction cardiotoxicity, arrhythmia, chest pain, hemorrhage, hypotension, hypertension, dyspnea, cough, pleural effusion, hypoxia, nausea, diarrhea\/ colitis, mucositis, constipation, abdominal pain, decreased appetite, vomiting, hemorrhoids, pruritus, petechiae, musculoskeletal pain, renal insufficiency, edema, fatigue, chills, pyrexia and catheter\/device\/ injection site reaction.1<\/sup><\/p>\n

“As a company dedicated to bringing life-changing medicines to market and redefining possibilities, the approval of Vyxeos<\/i> in Canada<\/span> represents Jazz’s promise of putting patients first,” said Paul Petrelli<\/span>, general manager, Jazz Pharmaceuticals Canada Inc. “Vyxeos<\/i> is an important example of how we meet the needs of the hematology and the oncology communities by offering a treatment that may extend life for high-risk AML patients.”<\/p>\n

\n Vyxeos<\/i> is part of a group of medicines called “antineoplastics” used against cancer.1<\/sup> It contains two medicinal ingredients, daunorubicin and cytarabine,1<\/sup> which are packaged in tiny particles known as liposomes.1<\/sup>Vyxeos<\/i>\u00a0is believed to kill cancer cells by stopping them from growing and dividing.1<\/sup> Packaging the medicinal ingredients in liposomes allows the drug to stay longer in the body.1<\/sup> The liposomes packaging also helps the drug enter the body and kill the cancer cells.1<\/sup><\/p>\n

\n About\u00a0Vyxeos
<\/i><\/b>
\n Vyxeos<\/i>\u00a0(daunorubicin and cytarabine liposome for injection) is a chemotherapy treatment option specifically indicated for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).1
<\/sup>Vyxeos <\/i>is administered by intravenous infusion over a period of 90 minutes.1<\/sup><\/p>\n

\n Vyxeos\u00a0<\/i>liposomes accumulate and persist in the bone marrow where they are taken up intact by\u00a0leukemia\u00a0cells to a greater extent than by non-leukemic\u00a0bone marrow cells\u00a0based on in-vivo animal studies.7<\/sup>\u00a0<\/p>\n

It is the first product to be developed with Jazz Pharmaceuticals’\u00a0CombiPlex\u00ae<\/sup> technology platform, which uniquely enables the design, rapid evaluation and delivery of various combinations of therapies.8<\/sup>\u00a0<\/p>\n

\n Important Safety Information for Canada<\/span>1
<\/sup><\/b>Vyxeos should not be given to patients who are:<\/p>\n