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Press Release

CALQUENCE® (acalabrutinib) Approved for Previously-Treated Mantle Cell Lymphoma, Available for Order at Biologics, Inc.

McKesson Specialty Health
Posted on: 01 Nov 17

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 one prior therapy.

CALQUENCE is a highly selective orally available potent inhibitor of Bruton’s tyrosine kinase (BTK). BTK is critical in the formation of B lymphocytes and plays an important role in their activation, signaling, spread and survival.1 CALQUENCE hinders the activity of BTK, preventing activation of the B-cell antigen receptor signaling pathway. This prevents both B-cell and BTK-mediated activation of downstream survival pathways, suppressing the growth of malignant B cells that overexpress BTK .2

Accelerated approval by The U.S. Food and Drug Administration on October 31, 2017 was based on clinical data from the acalabrutinib development program, including data from the Phase II ACE-LY-004 clinical trial in adult patients with relapsed or refractory MCL.3

Acalabrutinib is also in development for the treatment of multiple B-cell malignancies and other cancers including chronic lymphocytic leukemia, MCL, Waldenström macroglobulinemia, follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being studied as a monotherapy and in combination trials for the treatment of solid tumors. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have completed.4

Mantle cell lymphoma is a very aggressive B-cell non-Hodgkin lymphoma with a poor prognosis. In Western countries, the disease accounts for as much as 6 percent of new non-Hodgkin lymphoma cases each year, with an annual incidence rate of 0.5 per 100,000 persons and an estimated prevalence of 3.5 per 100,000.5 It occurs more frequently in older adults, with the average age at diagnosis in the mid-60s. The disease is more common in males than in females.6 Approximately 70 percent of patients have stage IV disease at diagnosis, presenting a poor prognosis since the cancer has already spread to other organs before detection.7

“Patients with mantle cell lymphoma who relapse or who cannot tolerate current therapy have very few treatment options today,” said Brandon Tom, vice president, Biopharma Services, McKesson Specialty Health. “We are excited to play a role in bringing this new therapy to patients facing this devastating disease.”

Biologics’ oncology specialty pharmacy is committed to providing patient-centric care throughout the patient’s cancer journey. The company is recognized across the industry for its high level of customer service and its innovative high-touch patient care model that supports patients with a multidisciplinary care team. Each team includes a pharmacist with in-depth knowledge of oncology pharmaceuticals, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and that streamline communication back to the treating provider, empowering high quality care and optimal outcomes.

Physicians may submit prescriptions to Biologics via phone (800-850-4306), fax (800-823-4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

About Biologics

Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payers and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk.

Biologics is part of McKesson Specialty Health, a division of McKesson Corporation empowering the community patient care delivery system by helping community practices advance the science, technology and quality of care. Through innovative clinical research, business and operational solutions, facilitated by integrated technology systems, we focus on improving the financial health of our customers so they may provide the best care to their patients. Our combined organization will help better support patients and expedite access to oncology therapies. For more information, visit www.mckessonspecialtyhealth.com and www.biologicsinc.com.

1. https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=756623

2. https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=756623

3. https://www.astrazeneca.com/media-centre/press-releases/2017/acalabrutinib-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-patients-with-mantle-cell-lymphoma-01082017.html

4. Data on File. REF US-15441. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

5. https://www.astrazeneca.com/media-centre/press-releases/2017/acalabrutinib-granted-breakthrough-therapy-designation-by-us-fda-for-the-treatment-of-patients-with-mantle-cell-lymphoma-01082017.html

6. https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf

7. http://www.medicinenet.com/mantle_cell_lymphoma_mcl/article.htm#mantle_cell_lymphoma_mcl_facts

View source version on businesswire.com: http://www.businesswire.com/news/home/20171101006480/en/

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Last updated on: 01/11/2017

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