LOUISVILLE, Ky.--(BUSINESS WIRE)--Onco360, one of the nation’s largest independent providers of Oncology Pharmacy services, today announced that it has been selected by Taiho Oncology, Inc. (“Taiho”) as a limited distribution pharmacy network participant for LONSURF® (trifluridine and tipiracil). With the addition of LONSURF, Onco360 continues to grow its broad portfolio of limited distribution oncology medications.
“We are pleased to be selected by Taiho to provide this important treatment to patients across the U.S.,” said Paul Jardina, President and Chief Executive Officer of Onco360. “This is yet another example of how our differentiated oncology pharmacy model is gaining traction and recognition in the marketplace. Onco360 is committed to providing patients with the most comprehensive oncology pharmacy care possible, and the addition of LONSURF provides us with an important new tool in the fight against cancer.”
On September 22, 2015, the U.S. Food and Drug Administration (FDA) approved LONSURF for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.1 In 2014, the American Cancer Society estimated that 136,830 people would be diagnosed with metastatic colorectal cancer (mCRC) in the United States.3 A subset of these patients will become candidates for treatment with LONSURF.
LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.2
Important Safety Information
WARNINGS AND PRECAUTIONS
Severe Myelosuppression: In Study 1, LONSURF caused severe and life-threatening myelosuppression (Grade 3-4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4 percent of LONSURF-treated patients received granulocyte-colony stimulating factors.
Obtain complete blood counts prior to and on Day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose.
Embryo-Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.
USE IN SPECIFIC POPULATIONS
Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LONSURF and for one day following the final dose.
Male Contraception: Advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.
Geriatric Use: Grade 3 or 4 neutropenia and thrombocytopenia and Grade 3 anemia occurred more commonly in patients 65 years old or older who received LONSURF.
Renal Impairment: Patients with moderate renal impairment may require dose modifications for increased toxicity. No patients with severe renal impairment were enrolled in Study 1.
Hepatic Impairment: Patients with moderate or severe hepatic impairment were not enrolled in Study 1.
Most Common Adverse Drug Reactions in Patients Treated with LONSURF (> or = 5 percent): The most common adverse drug reactions in LONSURF-treated patients vs placebo-treated patients with refractory mCRC, respectively, were: asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).
Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF-treated patients compared to placebo: infections (27% vs 15%), and pulmonary emboli (2% vs 0%).
Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.
Laboratory Test Abnormalities in Patients Treated with LONSURF: Laboratory test abnormalities in LONSURF-treated patients vs placebo-treated patients with refractory mCRC, respectively, were: anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).
Please see Full Prescribing Information.
|2.||LONSURF [prescribing information]; Princeton, NJ: Taiho Oncology, Inc.; 9/2015.|
|3.||Cancer facts & figures 2014. American Cancer Society.|
About Onco360® Oncology Pharmacy:
Onco360 (http://onco360.com) is one of the largest independent providers of Oncology Pharmacy services in the country. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. The Company’s clinical and dispensing model was developed specifically to meet the unique needs of oncology-treating physicians and their patients. Onco360 is advancing the continuum of oncology pharmaceutical care through patient advocacy, dispensing excellence, and the clinical experience and expertise that comes from its focus in oncology. Onco360 is headquartered in Louisville, KY and dispenses nationally through its network of URAC- and JCAHO-accredited Oncology Pharmacies. PharMerica Corporation (NYSE:PMC), a leading institutional pharmacy, specialty infusion and hospital services company servicing healthcare facilities in the United States, made a significant strategic investment in Onco360 in December 2013.
Onco360® | 1901 Campus Place | Louisville, KY 40299
About Taiho Oncology, Inc. (U.S.)
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has established a world class clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the U.S. Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.
For more information about Taiho Oncology, please visit: www.taihooncology.com
About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan and around the world for developing innovative medicines for the treatment of cancer. In areas other than oncology, as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical aims to also offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives.
For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/.
About Otsuka Holdings Co., Ltd. (Japan)
The Otsuka Group is a global organization of 176 healthcare companies with nearly 43,000 employees (including unconsolidated subsidiaries). Otsuka Holdings Co., Ltd. is the Group’s holding company. The Group operates in 27 countries and regions, conducting diversified businesses in four segments all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and others.6
The Group’s corporate philosophy of “Otsuka-people creating new products for better health worldwide,” is supported by the corporate ethic of “JISSHO (Proof through Execution) and SOZOSEI (Creativity).” The Otsuka Group thus seeks to foster a culture and vitality appropriate to an enterprise involved with human health and to create innovative products that contribute to the health and wellness of people worldwide.
For more information, please visit the company's website at http://www.otsuka.com/en/.
LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd. used under license by Taiho Oncology, Inc.