TURALIO (pexidartinib), FDA Approved Treatment of TGCT, Available at Biologics by McKesson

August 07, 2019

Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs

CARY, N.C. (August 7, 2019) Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, was selected by Daiichi Sankyo, Inc. as the exclusive specialty pharmacy provider for TURALIO™ (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

TURALIO, a first-in-class oral tyrosine kinase inhibitor for TGCT, was approved by the FDA on August 2, 2019. Surgery is the primary mode of treatment for TGCT associated with severe morbidity or functional limitations; however, some patients have disease that is not amenable to resection. For these patients, treatment options are limited because there are no approved systemic therapies for the disease. In February 2019, the FDA accepted, with Priority Review, a New Drug Application (NDA) for TURALIO based on results of the phase 3 ENLIVEN study, the first placebo-controlled study of a systemic investigational therapy in patients with TGCT.

TURALIO is approved with a Boxed Warning for the risk of serious and potentially fatal liver injury. Hepatotoxicity with ductopenia and cholestasis has occurred in patients treated with TURALIO. Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury. One patient died with advanced cancer and ongoing liver toxicity, and one patient required a liver transplant. The mechanism of cholestatic hepatotoxicity is unknown, and its occurrence cannot be predicted. It is unknown whether liver injury occurs in the absence of increased transaminases.

“We are pleased to be able to dispense this first systemic therapy for TGCT to patients,” said Ann Steagall, director of Clinical Policy, Biologics by McKesson. “It offers patients a treatment where surgery may not be an option. We’re excited to support TGCT patients as well as distribute another therapy in our growing portfolio of complex care. Due to the risk of serious and potentially fatal hepatotoxicity, TURALIO is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. As a leading provider of risk assessment and care planning, Biologics is proud to help ensure that patients taking TURALIO get the level of care they need and deserve.”

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of therapies, an experienced nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. Each patient speaks to a PharmD prior to dispense and has access to them 24 hours a day, seven days a week. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care, differentiated outcomes and improved adherence. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Clinicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, clinicians may search for Biologics within their EMR system.

About Biologics by McKesson

Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As part of McKesson Life Sciences, a business within McKesson Corporation, Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.

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