Is acalabrutinib approved for CLL?

Treatment with acalabrutinib is already approved for use in patients with CLL. Since ibrutinib is not always tolerated well by patients, acalabrutinib has positioned itself as an effective alternative treatment option.

When was acalabrutinib approved for CLL?

In November 2019, the FDA approved acalabrutinib for the treatment of adult patients with CLL or small lymphocytic leukemia based on data from ELEVATE-TN and ASCEND. The BTK inhibitor is also approved for CLL in several other countries worldwide, according to AstraZeneca.

When was Calquence approved for CLL?

On November 21, 2019, the FDA approved acalabrutinib (Calquence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

What is the difference between ibrutinib and acalabrutinib?

While ibrutinib is known to irreversibly inhibit both Btk and Tec, acalabrutinib exhibits a higher specificity towards Btk and less activity on Tec,⁹,¹⁹,²⁰ although a recent study suggests that its selectivity for Btk over Tec is not substantial.

How long has Calquence been around?

About Calquence

Calquence (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy.

Dr. Sharman on the Potential Approval of Acalabrutinib in CLL

Is Calquence FDA approved?

CALQUENCE was approved under FDA's accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

Which is better Imbruvica or Calquence?

Acalabrutinib (Calquence) was found to have a lower incidence of cardiovascular-related toxicities and a lower toxicity burden compared with ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL), according to John Seymour, MD, who added that because of these data, the former BTK inhibitor may be the ...

What are the side effects of acalabrutinib?

Is there an alternative to ibrutinib?

This finding suggests that acalabrutinib is a well-tolerated alternative for patients who have developed an intolerance to ibrutinib, says Leslie.

How is CLL 2020 treated?

Therapy: Only patients with active or symptomatic disease, or with advanced Binet or Rai stages require therapy. When treatment is indicated, several options exist for most CLL patients: a combination of venetoclax with obinutuzumab, ibrutinib monotherapy, or chemoimmunotherapy.

Is acalabrutinib an immunotherapy?

Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Is Calquence a new drug?

In 2019, the Food and Drug Administration (FDA) approved Calquence to treat CLL and SLL. The FDA approved Calquence to treat MCL in 2017. The drug received accelerated approval from the FDA for this use based on the overall response rate.

Is Acalabrutinib approved in the EU?

AstraZeneca's Calquence (acalabrutinib), a next-generation selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

Is Ibrutinib FDA approved?

HORSHAM, PA, January 29, 2015 – Janssen Biotech, Inc. (“Janssen”) today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA ^® (ibrutinib) capsules as the first therapy indicated specifically for patients with Waldenström's macroglobulinemia (WM), ¹ a rare, indolent type of B-cell lymphoma.

Who manufactures Acalabrutinib?

The trial was sponsored by AstraZeneca, which manufactures acalabrutinib. In the trial, 81% of patients experienced a clinical response to treatment, with responses split almost evenly between partial responses (41%) and complete responses (40%).

Does acalabrutinib cause hair loss?

Hair loss does not occur with acalabrutinib.

Is acalabrutinib a form of chemotherapy?

Acalabrutinib (pronounced [a KAL a broo ti nib]) is also known by the brand name, Calquence. It is a type of chemotherapy and an antineoplastic (anticancer) drug that belongs to a class called tyrosine kinase inhibitors (TKI). TKIs work by inhibiting the enzyme tyrosine kinase, thus blocking cell growth and division.

How long do you take acalabrutinib?

Acalabrutinib in Combination with Obinutuzumab: For patients with previously untreated CLL or SLL, the recommended dose is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start acalabrutinib at cycle 1 (each cycle is 28 days).

Is Calquence cheaper than Imbruvica?

Calquence charges about $170,000/ year (WAC price) compared to Imbruvica's $157,000. Given its level of clinical benefit, it is appropriately priced.

Can Imbruvica cure CLL?

Imbruvica Improves Outcomes in CLL, But Less Toxic Treatments Still Needed. Regimens containing Imbruvica bested chemoimmunotherapy treatments in elderly patients with chronic lymphocytic leukemia, but less toxic and long-term treatments are still needed.

What is the difference between ibrutinib and Imbruvica?

Imbruvica™ is the trade name for the generic drug ibrutinib. In some cases, health care professionals may use the generic name ibrutinib when referring to the trade name Imbruvica™.

Is Calquence considered chemotherapy?

How CALQUENCE Works. CALQUENCE is a targeted alternative to traditional chemotherapy for patients with CLL/SLL. It can be used for patients who have already received another treatment. CALQUENCE is a kinase inhibitor that affects the growth of CLL/SLL cancer cells.

Is Calquence limited distribution?

CARY, N.C. (November 1, 2017) —Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by AstraZeneca to be in the limited distribution network for CALQUENCE^® (acalabrutinib), a new oral treatment for adult patients with mantle cell lymphoma (MCL) who have received at least ...

How do you take acalabrutinib?

Acalabrutinib comes as a capsule to take by mouth. It is usually taken with or without food every 12 hours (twice a day) for as long as your doctor recommends that you receive treatment. Take acalabrutinib at around the same times every day.