The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the batch numbers

• PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
• 25A19E09 (UK/Ireleand pack, English language, 30 tablets á 15mg, Expiry date 10/2020).

The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers.

To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.

No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers. - so products with the above two batch numbers in UK/Ireland and English language are most likely falsified. In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging.

And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.

WHO alert

Incyte Press Release

Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.

In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at or +800 00027423.

Please let the CML Advocates Network know via if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.

Emerging news regarding CML Horizons 2019    

Dear members and friends of the CML Advocates Network,

You are probably aware of the terrible attack that took place yesterday by terrorists in the Dusit hotel in Nairobi. 

These are terrible and sad news indeed. Our thoughts are with the lost innocent victims and their families. We live in a crazy world with crazy people. Terror is taking lives in almost every country and it is so difficult to understand and accept. We must not react rashly, and will not make a decision based on emotion, but rather consider the alternatives and then make a decision.

The steering committee will now study the facts and the extent of the sad event and will discuss the implications of CML Horizons in Nairobi in May.

Meanwhile, we are not stopping registration as we already have more than 20 delegates registered, but we are stopping any activity that increases our costs and commitment like we will not book more flights until the Steering committee discusses the issue and makes a decision.

We are in constant touch with our local member organization, Henzo Kenya, and with our logistics agency Safari Trails to better understand the Situation in Nairobi and all safety steps taken now and in the near future.

We are evaluating the situation and we will come back to our members with more information and the final decision as soon as possible within 2 weeks.

We must decide what is best for Horizons and for all our members and delegates. We will put the safety of our participants at the top of our priority.

It is a sad day.

With our hopes for a better future
Giora and all the CML Advocates Network steering committee members.

 Register here - Preliminary Program - Conference fee -  Scholarship Application

Call for Poster - Call for Nominations Travel - Visas - Venue & Accommodation - Acknowledgements  

Registration is now open - Join us for the 17^th “CML Horizons: Learn. Share. Grow" Conference

DATE: 17th to 19th MAY 2019
LOCATION: Lisbon, Portugal

Due to events beyond our control and with sad regret we have changed the location of this year's Horizons. Even though location has been changed  to Lisbon, Portugal this does not take away from why we had chosen Nairobi as our original destination and that is to honour our dearly departed Ferdinand Micho who was a leader in the fight of CML in Africa and the Middle East but also for the challenges that CML patients face in low and middle-income countries in access to treatment and monitoring.

We have secured top speakers from Western countries like Dr. Francois Mahon & Dr. Gianantonio Rosti, also African and Asian countries such as Dr. Qian Jiang from China, Dr. Abinya from Kenya and Dr. Benneh from Ghana. More speakers are expected to confirm soon.

The CML Horizons conference is dedicated to the development of our members as patient advocates and deals with topics such as: - What is the goal of CML Treatment? Improving access, Key initiatives in CML treatment & advocacy and Living with CML and the future outlook. Dealing with these types of questions is the essence of Learn. Share & Grow and our conference offers the opportunity to support and facilitate the quality of education. This one of a kind conference also provides opportunities to be able to exchange ideas, interact & share best practice and provide a platform to start networking across borders, build alliances and so much more for you to bring back to your own organization.

We very much hope that you will be able to attend the 17th conference of its kind - with an exciting program on CML advocacy and CML science.

Our conference will provide you with knowledge on how to make a difference to the lives of patients, identify opportunities in patient support & advocacy and learn from the experts - both patient advocates and physicians by networking opportunities with CML advocacy leaders around the globe.

CLICK HERE TO REGISTER

We are proud to welcome a new member organisation to the CML Advocates Network: Asociacion Mexicana de Leucemia y GIST, A.C. based in Mexico.

The CML Advocates Network now totals at 120 member organisations in 90 countries worldwide!

See the list of CML groups in the Network on our world map.

With five approved tyrosine kinase inhibitors (TKIs) and none of them being curative, one may think whether there are still gaps to be filled with new CML drugs that follow similar mechanisms of action and not a totally different approach to eradicate the disease.

There is still a proportion of CML patients that does not respond to current TKIs properly or cannot tolerate them – and with non-effective treatment, they are at risk of life-threatening disease progression. Some CML patients sadly can’t access current 2^nd generation TKI (Dasatinib, Nilotinib, Bosutinib) or 3^rd generation (Ponatinib) drugs even if they would potentially address unmet medical need, e.g. in case of multi-resistent mutations. Additionally, about one third of CML patients achieve a good response on current TKIs but never get into MR4 remission, so they will not be able to try treatment-free remission (TFR) – so a more potent drug would probably increase “TFR probability” . There is also some concern on all current 2^nd generation TKI about side effects, e.g. cardiovascular side effects or pleural effusions, so a highly effective drug with a more favourable long-term toxicity profile and a better quality of life is certainly something CML patients would like to see. Of course the ultimate goal is cure of CML, which none of the current drugs achieve.

One new but also non-curative option is now on the horizon with Asciminib, formerly called ABL001, which was presented by Prof Delphine Réa from the Hôpital Saint-Louis, Paris, France at the ASH congress this year. Asciminib is in a way similar to other TKI, as it inhibits the CML-specific BCR-ABL and stops the proliferation of the CML cells. However, called an “allosteric inhibitor”, it binds at a different site of the protein than any of the other TKIs, and hence is not affected by the known mutations of the ATP pocket that actually render the current TKIs ineffective.

- ASH 2018 - CML Advocates Network Report by Giora Sharf -  

Every year in the last years I have been asked by Haematologists and also patients, why do I leave home for 6 days and fly across the world to ASH in the USA, as CML seems to be a conquered disease where the life expectancy of a patient is similar to a healthy person. When I think about it I have a few possible answers. 

First, ASH is the biggest and most important hematologic conference of the year where the newest data from clinical trials and real life are published at thousands of abstracts and posters in different sessions. 

Second, as I run today not only the Israeli CML patients organization but also the Flute of Light which is the home for blood cancers patients in Israel, I feel it is my responsibility to be at the place where new hopes and optimism are published for patients in different cancers like Lymphomas, CLL, Acute Leukemias and MPN. In addition, ASH is the place to meet with the top management of all the companies we work with and discuss how to strengthen our collaboration for more patients centric activities like patients engagement in clinical trials for example and improved access.

ASH opens every year on Friday with many satellite symposiums sponsored by Pharma on different diseases. This year there was no symposium on CML so I was able to attend the Advocates breakfast organized each year by Pfizer and the ICMLF meeting led by Tim Hughes which included talks on pregnancy in CML by Dragana Milosevic from the Hammersmith, Pediatric CML management by Prof Suttorp from Germany and talks by Dr Benneh from Ghana on CML management challenges in low-income countries.

CML wise the conference included the following sessions: The CML educational session, 3 oral sessions with 6 abstract presentations each, and posters presented at the end of each day at the posters session.

This report will summarize the main topics I found to be interesting at the oral and poster sessions. The main topics were new drugs in CML, TFR and Pregnancy and CML. 

If you want to read more info, you can find below each summary the link to the abstract presented.