peter Mac, page-2

Just copied this article mentioned by Letty.

Personally I am not a fan of current CAR-T but anything that helps is appreciated. Read below about the severe possible side effects. Of course if anyone had to choose between life and death then the choice is obvious. I am here just for trading, prefer IMU's tech.

Anyway, GLTA all sufferers and holders


EMBARGOED UNTIL 9:30 AEDT 28 JAN 2020


MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE
Novartis announces landmark steps for Kymriah®
(tisagenlecleucel): reimbursement for adult DLBCL
eligible patients and agreement to manufacture in
Australia
• Kymriah®, an innovative chimeric antigen receptor T cell (CAR-T) treatment, will be
publically funded for eligible adult patients with relapsed or refractory diffuse large
B cell lymphoma (DLBCL) in Australia
• Kymriah is currently the only CAR-T therapy approved by the Therapeutic Goods
Administration (TGA) for use in Australia.
[1] It is an immunocellular therapy, a onetime treatment manufactured individually for each patient using their own T cells,
genetically reengineered and programmed to recognise and destroy cancer cells
• Novartis and Cell Therapies have agreed to manufacture Kymriah at the Cell
Therapies’ production facility within the Peter MacCallum Cancer Centre in
Melbourne
Sydney, January 28th, 2020 - Novartis today announces that Kymriah® (tisagenlecleucel) will
be publicly funded following a recommendation from the Medical Services Advisory
Committee (MSAC) for the treatment of eligible adult patients with relapsed or refractory
diffuse large B cell lymphoma (DLBCL) in Australia.There are limited treatment options within
this patient group whose median life expectancy is approximately six months.
[2, 3]
.
Today’s announcement follows the reimbursement of Kymriah in eligible paediatric and young
adult patients up to 25 years of age with acute lymphoblastic leukaemia (ALL), which was
announced in 2019.
Novartis also announces today an agreement with Cell Therapies to manufacture Kymriah at
their production facility within the Peter MacCallum Cancer Centre in Melbourne. Cell
Therapies is an Australia-based, globally-active commercial contract development and
manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine,
and cellular immunotherapy products.
"Novartis is delighted about today’s announcements and the meaningful difference this
therapy can make to eligible patients in Australia," said Didier Dargent, Head of International
Markets Cell & Gene, Novartis Oncology. "I am also delighted that Novartis has signed an
agreement with Cell Therapies to manufacture Kymriah in Australia. Novartis has been a
pioneer in individualised medicine, making a bold early commitment to reimagine cancer care
in the emerging field of CAR-T therapies,” he added.
2
“CAR-T therapy is not like a traditional drug, it is a highly individualised cellular treatment,”
said Associate Professor Dominic Wall, who is Executive Director of Business Ventures at
Peter MacCallum Cancer Centre and Chief Scientific Officer at Cell Therapies.
“Unlike traditional therapies, CAR-T uses a patient’s own immune cells to fight some types of
blood cancers. To have this innovative cancer therapy approved in Australia, and now
manufactured locally for the first time, represents a major step forward for Australian patients
and clinicians,” he added.
“The decision to fund Kymriah for eligible patients with relapsed and refractory diffuse large Bcell lymphoma will dramatically change our treatment approach for this disease in Australia.
Its availability is a milestone in cancer treatment, and we welcome this announcement,” said
Dr Michael Dickinson, Peter MacCallum Cancer Centre.
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic
system, accounting for up to 40% of all NHL cases.
[4] Roughly one-third of patients with
DLBCL relapse after receiving first-line treatment.
[5] Out of those patients diagnosed with
DLBCL, about 10% have refractory disease and about 75% of patients who relapse or are
refractory to treatment are ineligible for autologous stem cell transplant. [2,4]
The Cell Therapies manufacturing facility within the Peter MacCallum Cancer Centre will be
used to supply patients with Kymriah in Australia and across the world. Novartis is in the
process of transferring the innovative manufacturing technology for Kymriah to Cell Therapies,
with the goal of manufacturing capabilities being ready in the second half of 2020.
Kymriah® (tisagenlecleucel) Important Safety information
SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Cytokine release syndrome;
Neurological events; Infections and febrile neutropenia; Prolonged cytopenias; Secondary
malignancies; Hypogammaglobulinemia; Live vaccines; Tumour lysis syndrome; Blood, organ,
tissue and cell donation; Active central nervous system (CNS) leukaemia or lymphoma;
Concomitant disease such as patients with a history of active CNS disorder or inadequate renal,
pulmonary or cardiac function; Prior bone marrow transplant; HIV, Hepatitis B, Hepatitis C and
viral reactivation; Prior treatment with an anti-CD19 therapy; Effects on laboratory tests; Use in
the elderly and paediatric use; Reasons to delay treatment such as Unresolved serious adverse
reactions, Active uncontrolled infection; active chronic GVHD, Significant clinical worsening of
leukaemia burden or rapid progression of lymphoma with unstable clinical presentation
following lymphodepleting chemotherapy; Patient information regarding adverse event
symptoms.