Onco360 Selected as a Limited Distribution Specialty Pharmacy Partner for Rytelo™ (imetelstat)
12 Julio 2024 - 6:30AM
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 oral, 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 trial1.
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) (952%), 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 OfficerBenito.Fernandez@Onco360.com516-640-1332
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).