New oral therapy is FDA approved for patients with advanced colorectal cancer
Phoenix, AZ— Avella Specialty Pharmacy announced today that it has been selected by Taiho Oncology, Inc. to distribute LONSURF® (trifluridine and tipiracil). LONSURF was approved by the U.S. Food and Drug Administration on September 22, 2015, 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.
Colorectal cancer is the third most common type of cancer and is the second leading cause of cancer-related deaths in the U.S.1 There were an estimated 136,830 U.S. patients diagnosed with cancer of the colon or rectum in 2014, and in 2012, an estimated 1.1 million individuals were living with the disease.2, 3 Of those, about 27,400 patients will have had their cancer spread to another part of the body.3
“We are excited to offer patients with refractory metastatic colorectal cancer an additional option to treat this condition,” said Leslie Yendro, RN, Vice President of Business Development for Avella Specialty Pharmacy. “By choosing Avella to be among the select group of pharmacies distributing this promising new therapy, Taiho Oncology has joined other leading manufacturers that recognize our commitment to clinical excellence.”
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% 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.
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 (≥5%): 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 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 for LONSURF at
LONSURF is a registered trademark of Taiho Pharmaceutical Co.,Ltd. used under license by Taiho Oncology, Inc.
About Avella Specialty Pharmacy
Headquartered in Phoenix, Arizona, Avella Specialty Pharmacy is a National Accredited Specialty Pharmacy, providing individualized care and support to patients since 1996. Avella's clinical pharmacists and staff members are experts in managing complex disease states and providing compassionate care. The company offers a nationwide distribution service to complement its retail locations. Avella reached 2,605th on Inc. Magazine's 2015 list of the 5,000 fastest-growing private companies in the country. In addition, the Arizona Corporate Excellence Awards has named Avella Specialty Pharmacy as the fastest-growing private company based in the state. For more information, please visit www.avella.com.
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.
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/.