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Faye Feller, executive vice president and chief medical officer at biopharmaceutical company Geron, was giving her child a bath when her husband came rushing into the bathroom with his cell phone.
“Something is going on,” he said. Geron’s blood cancer drug, Imetelstat (brand name Lytero), is a groundbreaking telomerase inhibitor. FDA approved.
Ferrer was immediately excited, but when he logged onto the company’s website after the announcement, the news “really hit me hard.”
“I saw a pop-up that said, ‘Accepted! Rytelo is coming to the U.S.,'” she says. “I just burst into tears.”
In the pharmaceutical and biotechnology industries, success is measured in decades. PhRMA Quote It takes an average of 10 to 15 years and $2.6 billion to develop a new drug, and even by those standards, Lytero’s road to approval has been a long one: The drug has been in development for 33 years, including “about 20 years of development in patients,” Ferrer said.
“We believe strongly in getting this mechanism to patients, and that’s been the case all along,” Ferrer said.
This mechanism is: Nobel Prize-winning science Telomeres are special DNA sequences at the ends of chromosomes that determine a cell’s lifespan, and telomerase is an enzyme that lengthens telomeres to keep cells alive.
“Cancer cells activate telomerase to maintain their immortality,” says Feller, “so by targeting cancer cells that have abnormally overexpressed telomerase, we can treat the underlying cause of the disease.”
After early studies of Imetelstat in other cancers, researchers saw indications in hematologic malignancies, according to Feller. Currently, Lytero is approved for adult patients with lower-risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia. Due to the anemia, these patients become dependent on frequent red blood cell transfusions, which can lead to poorer quality of life and shorter survival. Additionally, these patients require at least two transfusions per month and monitoring in between.
“I believed in my team, I believed in the drug, and as a drug developer, I thought this was the least risk I could take.”
Faye Feller
Executive Vice President and Chief Medical Officer, Geron
Rytelo offers patients the possibility to replace frequent and often unpredictable blood transfusions with monthly drug transfusions.
“We hope that this will alleviate some of the social (and) psychological burden of transfusions, in addition to the clinical benefits,” Feller said.
Winding Road
The long road to approval of the light terrorism project began with two scientists, Elizabeth Blackburn and Carol GreiderIn 1984, Dr. Blackburn discovered telomerase, which ultimately led to groundbreaking discoveries about the role of telomerase in cancer, the founding of Geron, where Dr. Blackburn and Dr. Greider served as scientific advisors, and ultimately to their Nobel Prize.
Geron put the drug’s development on hold several times over the years as he searched for the right cancer to target, even after identifying a blood and bone marrow malignancy that was finally discovered four years later when Janssen chose to end Collaboration and License Agreement for the Development and Commercialization of Imetelstat.
That termination is what drew Feller to Geron. Janssen had recruited her from Memorial Sloan Kettering Cancer Center in New York to work on imetelstat. After Janssen terminated their collaboration, Feller and her colleagues moved to Geron to continue working on the drug. She said the move to a small biotech was “scary, but definitely worth it.”
“I believed in my team and I believed in the drug,” she said. “As a drug developer, I thought this was the least risk I could take.”
Additionally, Ferrer thanked the “large investor community and financial institutions that have supported us along the way, believing in the science, the data, and the potential.”
Now the company is commercializing Rytelo and looking to expand its reach to larger markets. pipelineIt consists of multiple discovery, preclinical and clinical stage programs investigating telomerase inhibition in several myeloid hematologic malignancies.
Among them are Phase 3 Trials Efficacy of imetelstat in patients with JAK inhibitor relapsed/refractory myelofibrosis.
“We’re very proud that this is the first study in this patient field to look at overall survival as a primary endpoint,” Ferrer said. “If this study goes well, that will be our next indication.”
Regarding commercialization of Rytelo, Geron plans to launch to a “focused prescriber base (healthcare providers) of approximately 8,000 people.” “This will cover approximately 2,200 eligible accounts, with approximately 70% of patients expected to be treated in local hematology settings,” a company spokesperson told PharmaVoice in an email. Geron expects Rytelo to be available in distribution channels by the end of this month.
The company believes that Lytero could become part of the standard of care for the lower-risk MDP patient population, as there is high unmet need and “approximately (10%) of patients with lower-risk MDS… have very limited treatment options,” as other patient populations also have poorer outcomes and a high transfusion burden, according to a spokesperson.
According to the latest forecast, Rytelo’s sales are expected to reach $791 million in 2028, up from the $737 million predicted in April, and exceed $1 billion by 2030, an Evaluate spokesperson told PharmaVoice.
Ferrer says there’s now “tremendous enthusiasm and excitement” among doctors about getting Lytero to patients, and after popping the first bottle of champagne, she remains focused on further advances in telomerase inhibitor technology.
“With the approval, we will transition to a for-profit enterprise,” she said, “but it’s really important to me and it’s my duty to maintain our strong development.”
