By Priti Patel, MD, Vice President, Clinical Development, Hematology, AstraZeneca
Approximately every three minutes, a new patient is diagnosed with one of more than 130 different types of blood cancer.1,2 As a clinical drug developer, my role revolves around testing therapy options with the potential to help change the outlook for these blood cancer patients and provide them with hope for the future.
When I started my medical career, I was immediately drawn to the field of hematology. Not only was there a significant unmet need for those impacted by hematologic cancers, but I loved that the science was complex and rapidly evolving. I kept asking myself, “What more can we do for patients?” I continued digging deeper to better understand how these types of cancers are different, similar and unique.
That’s why five years ago, I joined a team of scientists at AstraZeneca who were exploring the potential of a new molecule for treating patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults, affecting an estimated 20,720 new patients in the US last year alone.3,4 We launched two important clinical trials, ELEVATE TN and ASCEND, that paved the way for this therapy to perhaps one day redefine blood cancer treatment.5,6
Last year, that molecule – CALQUENCE® (acalabrutinib) – was approved for the treatment of adult patients with CLL under the US Food and Drug Administration’s Real-Time Oncology Review and newly established Project Orbis program, a collaborative review process among participating countries, resulting in nearly simultaneous approvals by the US Food and Drug Administration, the Australian Therapeutic Goods Administration and Health Canada.7-9 This unprecedented collaboration was undoubtedly one of the highlights of my career – seeing first-hand culmination of years of my team’s relentless pursuit that led to a breakthrough medicine with the potential to help those living with CLL throughout the world.
Experiences like these, where science and patient need intersect, energize me. At AstraZeneca, I lead clinical development for multiple blood cancers, including CLL, where our scientific approach is informed by a deep understanding of patients’ needs. We demonstrated this in the ELEVATE TN trial, as tolerability remained a big focus of ours, knowing that individuals with CLL tend to be elderly and may be managing other health complications.10-12
But our work isn’t done. I’m fortunate to work with a team that has an insatiable curiosity like I do to dive into the “what’s next?”
It has been incredibly inspiring to see science translate to tangible advancements for patients. I’m grateful to spend every day discovering the potential of new medicines and to play a role in bringing new options to patients with CLL and other blood cancers, and I’m excited for what the future holds.
What is CALQUENCE?
CALQUENCE is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
It is not known if CALQUENCE is safe and effective in children.
Important Safety Information About CALQUENCE® (acalabrutinib) capsules
Before taking CALQUENCE, tell your healthcare provider about all of your medical conditions,
including if you:
- have had recent surgery or plan to have surgery. Your healthcare provider may stop CALQUENCE for any planned medical, surgical, or dental procedure.
- have bleeding problems.
- have or had heart rhythm problems.
- have an infection.
- have or had liver problems, including hepatitis B virus (HBV) infection.
are pregnant or plan to become pregnant. CALQUENCE may harm your unborn baby and cause problems during childbirth (dystocia).
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with CALQUENCE and for at least 1 week after the last dose of CALQUENCE
- are breastfeeding or plan to breastfeed. It is not known if CALQUENCE passes into your breast milk. Do not breastfeed during treatment with CALQUENCE and for at least 2 weeks after your final dose of CALQUENCE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking CALQUENCE with certain other medications may affect how CALQUENCE works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine.
How should I take CALQUENCE?
- Take CALQUENCE exactly as your healthcare provider tells you to take it.
- Do not change your dose or stop taking CALQUENCE unless your healthcare provider tells you to.
- Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects.
- Take CALQUENCE 2 times a day (about 12 hours apart).
- Take CALQUENCE with or without food.
- Swallow CALQUENCE capsules whole with a glass of water. Do not open, break, or chew capsules.
- If you need to take an antacid medicine, take it either 2 hours before or 2 hours after you take CALQUENCE.
- If you need to take certain other medicines called acid reducers (H2-receptor blockers), take CALQUENCE 2 hours before the acid reducer medicine.
- If you miss a dose of CALQUENCE, take it as soon as you remember. If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of CALQUENCE at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.
What are the possible side effects of CALQUENCE?
CALQUENCE may cause serious side effects, including:
- Serious infections can happen during treatment with CALQUENCE and may lead to death. Your healthcare provider may prescribe certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms.
- Bleeding problems (hemorrhage) can happen during treatment with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or you cannot control, vomit blood or vomit that looks like coffee grounds, cough up blood or blood clots, dizziness, weakness, confusion, changes in your speech, headache that lasts a long time, or bruising or red or purple skin marks
- Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with CALQUENCE.
- Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin or other organs. Your healthcare provider will check you for skin cancers during treatment with CALQUENCE. Use sun protection when you are outside in sunlight.
- Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms: fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath
The most common side effects of CALQUENCE include headache, diarrhea, muscle and joint pain, upper respiratory tract infection, and bruising.
These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
1 Leukemia & Lymphoma Society of Canada. Facts and Statistics. Accessed May 2020.
2 Leukemia & Lymphoma Society. Facts and Statistics. Accessed May 2020.
3 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Accessed May 2020.
4 American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Accessed May 2020.
5 Acerta Pharma BV. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NLM identifier: NCT02475681. Accessed May 2020.
6 Acerta Pharma BV. A Study of Acalabrutinib vs Investigator’s Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. NLM identifier: NCT02970318. Accessed May 2020.
7 CALQUENCE®(acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
8 U.S. Food and Drug Administration. Project Orbis: FDA approves acalabrutinib for CLL and SLL; November 21, 2019. Accessed May 2020.
9 U.S. Food and Drug Administration. Project Orbis. Accessed May 2020.
10 Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019;134 (1 Suppl):31.
11 Barrientos JC. Management of Chronic Lymphocytic Leukemia in the Elderly. Cancer Control. 2015;22(4 Suppl):17‐23.
12 Smolej L. Therapeutic Approach to Patients with Chronic Lymphocytic Leukemia and Significant Comorbid Conditions. Curr Cancer Drug Targets. 2016;16(8):710-720.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©2020 AstraZeneca. All rights reserved.
US-40462 Last Updated 5/20