CARY, N.C. (May 3, 2017) — Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected by Novartis to be in the distribution network for RYDAPT® (midostaurin), a new oral treatment for adults with newly-diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. The AML treatment strategy has remained virtually unchanged for more than 25 years,1 so the development of RYDAPT is a welcomed advancement in cancer care and gives providers another treatment option for this challenging disease.
On April 28, 2017, the US Food and Drug Administration (FDA) approved RYDAPT for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is also approved to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). The drug received Priority Review in November of last year, signifying the importance of RYDAPT as a potential therapy to fulfill significant unmet needs for these patients who have not previously had access to targeted medicines.
Each year, more than 20,000 cases of acute myeloid leukemia are diagnosed in the United States, and it is the most common form of leukemia found in adults.2 The disease has a low survival rate, with approximately 27 percent of patients living five years or more after diagnosis.3 Roughly one-third of patients with AML have FLT3 mutations which are associated with a higher risk of relapse and shorter survival duration.4
Approval of RYDAPT is based on the Phase III RATIFY clinical trial, where newly diagnosed FLT3+ patients who received RYDAPT plus chemotherapy experienced significant improvement in overall survival with a 23% reduction in the risk of death compared with chemotherapy alone. Event-free survival (EFS) was significantly higher for patients receiving RYDAPT plus chemotherapy versus chemotherapy alone – a median of 8.2 months compared to 3.0 months.5
“FLT3-mutated AML is a rare and aggressive disease, with very limited existing treatment options,” said Brandon Tom, vice president, Biopharma Services, McKesson Specialty Health. “We look forward to offering this subset of AML patients access to this encouraging new therapy while also providing high-touch support to help improve outcomes for this patient population.”
Biologics’ oncology specialty pharmacy is recognized throughout the cancer care community for its unique, personalized patient-centric care model. Biologics supports patients with a highly-skilled, compassionate multidisciplinary care team that includes a pharmacist, oncology nurse and financial counselor who work closely together on behalf of the patient. Individualized care plans are developed to address the unique clinical, financial and emotional needs of each patient and to streamline communication back to the treating provider, enabling optimal outcomes and a better patient experience.
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.