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Onco360® , the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Geron Corporation for Rytelo™ (imetelstat) as a first in class infusion, oligonucleotide telomerase inhibitor, approved for the treatment of adult patients with low to intermediate risk myelodysplastic syndromes (MDS) with transfusion dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). This indication was approved based on the results from IMerge Phase 3 clinical trial 1 .
Rytelo™ (imetelstat) works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In low to intermediate risk MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division.
“Onco360 is excited to partner with the team at Geron and become a specialty pharmacy provider for Rytelo™,” said Benito Fernandez, Chief Commercial Officer. “We continue to see therapeutic advancements that are helping to further our mission of improving the lives of patients battling cancer, rare, and orphan disease. There are very few options today for patients with lower-risk MDS and anemia who are transfusion dependent, and Rytelo™ is a great addition to our portfolio of oncology products.”
MDS is a group of disorders that result in the inability to produce enough healthy mature blood cells. The incidence of MDS in the general population is 4.5 per 100,00 people per year. 2 The major clinical problems in these disorders are morbidities caused by cytopenias and the potential for MDS to evolve into acute myeloid leukemia (AML).
The FDA approval of Rytelo™ based on the IMerge Phase 3 clinical trial, met its primary and key secondary endpoints, with Rytelo™ demonstrating significantly higher rates of red blood cell transfusion independence vs placebo for at least eight consecutive weeks Rytelo™ 39.8% (95% CI 30.9-49.3) vs placebo 15% (95% CI 7.1-26.6), and for at least 24 weeks Rytelo™ 28% (95% CI 20.1-37) vs placebo 3.3% (95% CI 0.4-11.5).
The most common grade 3 or 4 adverse events for Rytelo™ were neutropenia (72%) and thrombocytopenia (65%), which lasted a median duration of less than 2 weeks, and 80% of patient resolve to grade 2 or less in under 4 weeks. The cytopenias were generally managed with dose modifications. The most common adverse reactions ( ≥ 10% with a difference between arms of > 5% compared to placebo), including laboratory abnormalities, were decreased platelets (97%), decreased white blood cells (94%), decreased neutrophils (neutropenia) (92%), increased aspartate aminotransferase (AST 53%), increased alkaline phosphatase (Alk Phos 48%), increased alanine aminotransferase (ALT 43%), fatigue (29%), prolonged partial thromboplastin time (26%), arthralgia/myalgia (25%), COVID-19 infections (19%), and headache (13%).
Please see the full Prescribing Information for Rytelo™ .
About Onco360 Oncology Pharmacy: Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. 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. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact Benito Fernandez, Chief Commercial Officer Benito.Fernandez@Onco360.com 516-640-1332
References: [1] Platzbecker, U. et al. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. Volume 403, Issue 10423, P249-260. Jan 20, 2024. [2] National Cancer Institute. SEER cancer statistics review 1975-2016: Myelodysplastic syndromes (MDS), chronic myeloproliferative disorders (CMD), and chronic myelomonocytic leukemia (CMML).