CALQUENCE gets FDA approval for treating CLL - CLL Support

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CALQUENCE gets FDA approval for treating CLL

Myrddin profile image
11 Replies

The latest approval for Calquence (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor, was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programs. Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

11 Replies
PlanetaryKim profile image

Very good news for CLL folks in the US.

AussieNeil profile image
AussieNeilAdministrator in reply to PlanetaryKim

Extremely importantly, this announcement is a huge international breakthrough for people in many countries with cancer, looking for improved treatment approvals. Up until now, new treatment drugs were nearly always first approved by the FDA in the USA, with other countries eventually following up to years later - if ever. This is the first Project Orbis announcement of an approval for a new CLL drug impacting not only those with CLL in the USA, but also concurrently for those with CLL in Australia and hopefully soon Canada! (In Canada and Australia, we still have to await funding approval so the drug is affordable, but at least it can be legally prescribed!)

In 2004, FDA’s Office of Hematology and Oncology Products (OHOP) began holding regular teleconferences under a confidentiality agreement with other regulatory agencies to allow for exchange of information and collaboration on specific topics related to applications under review. Currently, OHOP holds a monthly teleconference with Australia’s Therapeutic Goods Administration, Health Canada, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and Switzerland’s Swissmedic. In addition, FDA and China’s National Medical Products Administration have initiated a quarterly meeting to discuss non-product specific regulatory issues facing worldwide drug development.

The first Project Orbis action took place on September 17, 2019, in conjunction with the Australian Therapeutic Goods Administration and Health Canada.



Myrddin profile image
Myrddin in reply to AussieNeil

Great that a new option will be available in the future and by a European company too. Unfortunately like Shingrex we will have to wait quite a while before it will be available in UK. Upside is by the time it is available we will know more about any side effects.

Yidarmy69 profile image
Yidarmy69 in reply to Myrddin

Hi I’m in uk and on a trial taking Acalabrutinib been-on it for 3 weeks my enlarged noades gone in January I start venclolax on this trial no adverse reaction from Acalabrutinib

AdrianUK profile image
AdrianUK in reply to Yidarmy69

Great to hear you are doing well. Are you also using obinituzimab or just A and V? Both with and without obinituzimab it’s believed that the A and V combo will hopefully turn out to be really powerful in CLL. A on its own typically does a great job of driving the CLL cells out of the nodes and shrinking them. The idea now is Venetoclax can come along and kill them easily in the blood. Hope it works really well for you!

Yidarmy69 profile image
Yidarmy69 in reply to AdrianUK

Thank you I will keep everyone updated when I start on the Venetoclax in January new year

Myrddin profile image
Myrddin in reply to Yidarmy69

that would be great

Myrddin profile image
Myrddin in reply to Yidarmy69

Brings the chance of it being used outside of a trial a bit closer - great that you are in a trial and doing well

Yidarmy69 profile image
Yidarmy69 in reply to Myrddin

Thank you

Smakwater profile image

Good posting myrddin,

Thanks for the Bloodwise presentation link as well. Fascinating information.


Myrddin profile image
Myrddin in reply to Smakwater

All great stuff even though not all directly cll related, though several mentions as well as a cll patients story. Good to hear about other blood cancer treatment developments which potentially may help us in the long run. Encouraging to know blood cancer research is still such hot topic

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