COPIKTRA is a dual inhibitor approved for treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and relapsed or refractory follicular lymphoma
CARY, N.C., September 26, 2018—Biologics, McKesson’s independent oncology and complex care specialty pharmacy, has been selected by Verastem Oncology™ to be in the limited distribution network for COPIKTRA™ (duvelisib), a first-in-class oral dual inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
COPIKTRA is the first and only oral dual phosphoinositide-3-kinase (PI3K)-delta, P13K-gamma inhibitor on the market. Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.¹ In the Phase III trial, COPIKTRA was shown to reduce the risk of disease progression or death by 48% in patients with relapsed/refractory CLL.² The FDA’s full approval of COPIKTRA as a safe and effective treatment of CLL/SLL was based on positive data from the Phase 3 DUO™ trial. Based on the overall response rate (ORR) results of the Phase 2 DYNAMO trial, the FDA has also granted accelerated approval of COPIKTRA for the treatment of patients with FL.
“Previously, patients with relapsed/refractory forms of CLL/SLL and FL had limited treatment options,” said Brandon Tom, vice president, Commercial Services, Biologics, Inc. “We are pleased to be able to offer this much needed new drug to these patients, who are able to receive an oral therapy treatment in the convenience of their homes.”
Biologics’ oncology specialty pharmacy is committed to providing patient-centric care throughout the patient 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. With therapies like COPIKTRA each patient receives care from a team that includes a pharmacist with in-depth knowledge of oncology therapies, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help 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.
¹ http://www.verastem.com/focus/pi3k-inhibition/
² https://www.onclive.com/web-exclusives/duvelisib-improves-pfs-in-phase-iii-cll-trial
About COPIKTRA (duvelisib)
COPIKTRA is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), which has Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Biologics
Biologics, Inc. is an independent provider of oncology and complex-care specialty pharmacy services. We enable healthcare providers, payers and biopharma and life sciences companies to optimize patient care for the best possible outcomes – clinical, financial and emotional. We unify fragmented healthcare services and bring humanity to specialty care management by focusing on the patient’s best interest and outcomes. Biologics is part of McKesson Corporation.