Genentech: Rituxan improved asymptomatic follicular lymphoma symptoms among patients in trial
SOUTH SAN FRANCISCO, Calif. — A biotech drug made by Roche subsidiary Genentech allowed patients with a blood cancer, who did not show symptoms, to delay starting on chemotherapy or radiotherapy, and decreased the risk of their disease worsening, according to results of a late-stage clinical trial.
Genentech said results of the trial of Rituxan (rituximab) showed that patients with asymptomatic follicular lymphoma who immediately received the drug fared better than those who took a “watchful waiting approach,” meaning they waited until the disease began showing symptoms and worsening. Compared with the “watchful waiting” approach, patients receiving Rituxan decreased the risk of needing additional therapy by 80% and decreased the risk of the disease worsening by 79%.
“These are the first phase-3 data to have shown that initial use of Rituxan monotherapy as induction followed by maintenance had an impact in patients with asymptomatic follicular lymphoma, a disease that is commonly treated only after symptoms appear,” Genentech EVP product development and chief medical officer Hal Barron said. “Early treatment interventions in prior studies in this population were not considered to provide meaningful clinical benefit.”
ACRO specialty pharmacy symposium addresses market growth, health reform
PHILADELPHIA — The specialty pharmacy market is set to reach $90 billion this year, so it’s clear that managed care organizations have a lot at stake.
That was the overarching theme at a symposium organized by specialty pharmacy provider ACRO Pharmaceutical Services, in conjunction with Armada Health Care, last Thursday at the Hyatt Regency at Penn’s Landing in Philadelphia.
The symposium included presentations by Russel Allinson, CEO and chief clinical officer of specialty pharmacy consulting and analytics company Therigy; and Mesfin Tegenu, president of pharmacy benefit manager PerformRx; as well as a keynote speech by Eric Elliott, president and CEO of PBM Prime Therapeutics; and a panel discussion about various specialty pharmacy and payer issues featuring executives from several payer organizations.
Elliott’s speech focused on healthcare reform and the healthcare environment that will take shape as a result of it. Specifically, Elliott suggested that PBMs and insurers should look at what kind of market will exist after the Patient Protection and Affordable Care Act takes full effect rather than focusing on how to implement reform.
“The thing about healthcare reform is that it’s not yet completely clear what it is,” Elliott said, saying that increased access would be the most visible outcome. The Congressional Budget Office projected that 22 million Americans will be uninsured by 2019 under the healthcare-reform bill, compared with 54 million had the bill failed.
Despite increased access, drug companies will make less money as a result of the bill’s creation of a regulatory approval pathway for biosimilars. “Healthcare reform and the clear pathway created where one didn’t exist before will have a negative impact on brand revenues,” Elliott said.
Following Elliott’s speech, a panel of payer organization executives participated in a question-and-answer session on such issues as specialty drugs and strategies after healthcare reform, limited distribution drugs, health plan-preferred or exclusive specialty pharmacy networks, REMS and biosimilars.
Amgen: Nplate may help patients with autoimmune bleeding disorder
ORLANDO, Fla. — A drug made by Amgen maintained blood platelet counts in patients with an autoimmune bleeding disorder, according to results of a five-year study released Sunday.
Amgen announced results of its study of Nplate (romiplostim) in adults with chronic immune thrombocytopenic purpura, in which the body’s own immune system destroys platelets, necessary for clotting of the blood. Results of the study, which showed that 95% of the 292 patients receiving the drug maintained platelet counts, were presented at the annual meeting and exposition of the American Society of Hematology.
“In this study, nearly all Nplate-treated patients were able to maintain platelet counts within the target range for more than five years,” said David Kuter, lead study investigator and chief of hematology at Boston’s Massachusetts General Hospital.