US FDA Approves AstraZeneca New Tablet Formulation of Calquence


The US FDA approved the new tablet formulation of Calquence by AstraZeneca in the United States for all current indications, including patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), and patients with relapsed mantle cell lymphoma.

The approval by the US FDA was based on results from the ELEVATE-PLUS trials presented at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021. In the trials, results showed the Calquence capsule and tablet formulations, and indicated the same efficacy and safety profile could be expected with the same schedule and dosing strength.

The US approval of the formulation in a tablet form enables co-administration of the acalabrutinib tablet along with a proton pump inhibitor. This also provides another option for some patients with chronic lymphocytic leukaemia, and relapsed mantle cell lymphoma, enabling more patients to benefit from this treatment.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said the approval of the new Calquence tablet formulation will offer patients and physicians increased flexibility when devising treatment plans for mantle cell lymphoma and chronic lymphocytic leukaemia.

See also  UC Davis to Develop AI Technology to Predict Risk and Detection of Breast Cancer

He also said this new treatment option is a result of their focus on understanding the wants, and needs of the community, and providing solutions based on their treatment focusing on the patients. Calquence is also approved as a capsule formulation for similar indications as tablet in the United States.


Writing is a medium to express feelings and convey facts. A creative mind never rests in peace and this amazing platform gives me the freedom to write about what I like most.

I’ve been a writer/blogger for the last twelve years and have covered technology-related topics. However, I also have considerable years of experience in writing for various domains – Technology, Beauty, Fashion, Pharmaceutical, human psychology etc. Technology is my forte.

I’ve handled many interesting projects. Writing is my passion. As an author, I’ve learned a lot in my long journey of penning down my thoughts!