Roche Canada announced that Health Canada has approved GAZYVA™ (obinutuzumab) to be administered in combination with chlorambucil chemotherapy for the treatment of people with previously untreated CLL.
This is approval for safety and efficacy. It is not available or funded in the clinic yet.
Janssen Inc. announced today Health Canada has approved IMBRUVICA™ (ibrutinib) for the treatment of the blood cancer chronic lymphocytic leukemia (CLL). It is indicated for the treatment of patients with CLL, including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion.
In CLL, 17p deletion is a genetic mutation that has been associated with poor treatment outcomes.
This DOES NOT MEAN IT IS FUNDED by the provinces yet... it is the first step...
' British Columbia (BC) Cancer Agency has had an international reputation for excellence in care and research. But the foundations of that success are crumbling as patient wait times increase, staff workload surges, oncologists quit, and burnout becomes common, according to news reports.
The deteriorating conditions have sparked a letter of protest from three top doctors at the center, a copy of which was obtained and excerpts reported by a leading Canadian newspaper, The Globe and Mail.' See link below...
The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending GlaxoSmithKline's Arzerra (ofatumumab) in a form of leukaemia.
NICE, which provides health guidance for the NHS in England and Wales, said the drug was a cost-effective option in combination with chlorambucil for untreated chronic lymphocytic leukaemia (CLL) in people who are not eligible for treatment with fludarabine combination therapy and for whom bendamustine is unsuitable.
Ofatumumab’s list price is £182 for a 100 mg vial and £1820 for a 1000 mg vial. Assuming 6 cycles and no drug wastage, the mean cost of a treatment course for ofatumumab at its list price is £11,466 for 6300 mg. The company has agreed a patient access scheme with the Department of Health that makes ofatumumab available with a discount on the list price.
Nov 4, 2014
DailyMed provides trustworthy information about marketed drugs in the U.S.
DailyMed is the official provider of FDA label information (package inserts).
This new redesigned Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.
To view a specific section in the listing, click or tap on the 'orange plus, beside a topic. The information is also available in PDF format ...to download
This particular page link is for ibrutinib, but you can search any drug in the database of FDA approved treatments...
Oct 21, 2014
ibrutinib/gazyza combo deal
Pharmacyclics Enters Into Agreement with Roche to Evaluate IMBRUVICA® and GAZYVA® in Lymphoma and Leukemia
[i] Pharmacyclics, Inc. announced that it has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA® (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in combination with GAZYVA® (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body's immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
The agreement allows for multiple studies to be considered and conducted. Initially, a Phase 3 study will be conducted by Pharmacyclics in CLL/SLL.
The National Institute for Health and Care Excellence (NICE) has issued new draft guidance that does not recommend Roche's Gazyvaro for untreated chronic lymphocytic leukemia.
“Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources," said NICE's chief executive, Andrew Dillon.
"With limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS.”
NICE Guidelines Document
Oct 3rd 2014
October LLSC CLL Patient Meetings
Making Informed Decisions for Chronic Lymphocytic Leukemia: Standards of Care & Clinical Trials
Zydelig is FDA approved in combination with rituximab for patients with relapsed CLL AND as a single agent (no rituximab) for patients with follicular lymphoma / small lymphocytic lymphoma who have become refractory to rituximab AND alkalating agents (bendamustine, chlorambucil, Cyclophosphamide).
Cost in the US are expected to be in the ballpark of $7200 a month plus rituxan, for a total of about $12,000 monthly
sccording to some Wall Street pundits...
GSK and Genmab receive EU authorisation for Arzerra™ (ofatumumab) as first-line treatment for chronic lymphocytic leukaemia (CLL) in combination with chlorambucil or bendamustine for patients ineligible for fludarabine-based therapy.
July 4, 2014
Two CLL treatments start Canadian process for funding recommendation to the provinces
Treanda(in combination with rituximab) aka bendamustine/rituxan BR has started
the pCODR process for recommendations to the provinces (except Quebec) for first line CLL only. This follows
on a previous application for Arzerra, aka ofatumumab, combination with chlorambucil, for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy.
The CLL Support Association (CLLSA) is a patient led support charity founded in the UK In 2005. The remit of the CLLSA is to provide support to CLL/SLL patients and their families by keeping them informed of recent and relevant developments in CLL/SLL treatment and research and to provide opportunities for awareness raising and mutual support. The association has a dual role of encouraging education and self development while working to improve access to CLL/SLL treatments and care that will improve outcomes.
CLLSA at HealthUnlocked brings together an international on-line community to allow sharing of experiences of living with CLL/SLL within a supportive group who do "get it", supported by reliable international information resources and perspectives. This partnership will with your help continue to develop as a resource that helps many
In a first-of-its-kind report, World Health Organization (WHO) announced today that bacterial infections that can’t be treated with the antibiotics of last resort have emerged in every part of the world, which means that patients who pick up E. coli, pneumonia or staph infections don’t have an effective way to control their illnesses.
In some countries, more than half of people infected with K. pneumonia bacteria won’t respond to carbapenems. A similar percentage of patients with E. coli infections won’t be helped by taking fluoroquinolone antibiotics.
Fairly chilling report for the immunocompromised, like CLL patients...
How we treat Richter Syndrome... from CLL experts at the Mayo Clinic
Richter syndrome (RS) is defined as the transformation of chronic lymphocytic leukemia (CLL) into an aggressive lymphoma, most commonly diffuse large B-cell lymphoma (DLBCL). RS occurs in approximately 2% to 10% of CLL patients during the course of their disease, with a transformation rate of 0.5% to 1% per year.
Richter's can occur at any time, but the length of time to first treatment and chemoimmunotherapy are factors.
On March 10, 2014, an unprecedented unification of more than 30 Canadian patient groups, physicians and health care charities and led by Kidney Cancer Canada, launched CanCertainty, a campaign calling for equal and fair treatment for all Canadians.
CanCertainty represents a growing coalition of organizations working together to ensure all Canadian cancer patients will have fair and equal access to the treatment they need, whether intravenous (IV) or oral. As an umbrella organization focused on advancing patient and caregiver interests, the Canadian Cancer Action Network (CCAN) is proud to support this effort financially as we lend our voice to the following call for action to the governments of Ontario,Nova Scotia, Prince Edward Island, New Brunswick, and Newfoundland and Labrador to join the rest of the country in providing fair and equivalent access to oral and IV anti-cancer treatments.
According to the attached white paper developed by the Cameron Institute, a not-for-profit, public policy think tank, “it is estimated an investment of $28 - $93 million will ensure all patients in Ontario have access to oral medications. The investment is also estimated to lead to at least a 17 per cent reduction in overall chemotherapy unit costs. The same holds true, proportionally, for Nova Scotia and Newfoundland and Labrador as well.” For more information, including the CNW press release, relevant background information, please visit the link below.
Imbruvica (Ibrutinib) FDA approved in previously treated CLL
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
This applies to use in the U.S. only. Hopefully the Health Canada approval will follow and then
the pCODR funding studies and recommendations to the provinces can begin. This can be a lengthy
process. For more information on Cancer Drug Approvals in Canada here is a good overview...
A Canadian Perspective on the Treatment of Unfit Patients with Chronic Lymphocytic Leukemia
This paper discusses two major issues physicians encounter when treating unfit patients with CLL: (i) What factors enter into the decision that a patient is unfit for FCR therapy? (ii) What are the best treatment options for those patients who are deemed unfit? In addition to reviewing the current evidence, the regional practices of three Canadian experts from Nova Scotia, Quebec, and Alberta will be explored.
PDF LINK HERE
Feb 3 , 2014
Health Canada/GSK on Arzerra (ofatumumab) and HepB
GSK, in consultation with Health Canada, would like to inform you of important new updates to the recommendations for screening, monitoring and management of Hepatitis B reactivation in patients treated with ARZERRA™ (ofatumumab).
ARZERRA™ is an anti-CD20 antibody that is authorized in Canada under a Notice of Compliance with conditions, for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.
SEE DETAILS... LINK HERE
January 27, 2014
New CLL trial in Toronto
New Phase 1/2 clinical trial for Ruxolitinibn by Dr. Spaner at Sunnybrook in Toronto for 65 and over who are unfit for FCR... also 17p deleted of any age.
Details LINK HERE
January 10, 2014
LLC en français?
This is a link to a French CLL/SLL website...
might give it a try.
Dec 10 , 2013
How Cancer Drugs are Approved and Funded in Canada
This tutorial explains the process that decision makers in Canada follow to decide whether to publicly fund new cancer drugs. You’ll learn who is involved in this process, and how health benefits, costs and values play into the decision. At the end of the tutorial, you should be able to answer the following questions:
Which groups make decisions in Canada about publicly funded cancer drugs and how are those decisions made?
◊ How do we know if drugs work and are better than current treatment?
◊ How do costs and benefits fit into the decision making process?
◊ What is a fair decision?
◊ How are decision makers held accountable to the public?
◊ How can you get involved in cancer drug funding decision making panels?
The principles described in this tutorial also apply to decisions about other non-
cancer drugs and new health care technologies.
LINK HERE PDF TUTORIAL
Nov 2, 2013
Gazyva, obinutuzumab...FDA APPROVED
The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
FDA LINK HERE
Nov 1 , 2013
Flow Cytometry ~ Everything you need to know and more...
Flow Cytometry is a blood test used to diagnose CLL. This video tutorial education program explains how flow cytometry actually works.
This takes about 12 minutes to view... Will NOT work on iPad etc. Needs Flash Player 8
Information on the CLL CANADA website (www.cllcanada.ca) is intended to be used for general information and educational purposes
and should not replace consultation with healthcare professionals. The information on this site is provided by CLL patients and caregivers.
Consult a qualified healthcare professional before making any medical decisions or if you have questions about your individual medical situation. Please, do not self medicate.