Roche said Monday that its bispecific T-cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth.
Tag Archive for: lymphoma
Regeneron Pharmaceuticals said the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma, raising concerns over the progress of ongoing confirmatory trials.
The company stated that Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen.
While a majority of adults recognize leukemia as a blood cancer, a new survey by The Leukemia & Lymphoma Society (LLS) found that a low percentage of respondents associate the following diseases with a blood cancer: lymphoma (including Hodgkin’s lymphoma), myeloma, myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPNs).
Already approved in later stage and high-risk cHL, the goal of ongoing Adcetris studies is to “develop curative treatments that improve survival while also reducing toxicity,” Jeremy Abramson, director of the Jon and Jo Ann Hagler Center for Lymphoma at Massachusetts General Hospital and principal investigator for the Phase II trial, said in a statement.
California-based Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate GB5121 following two patient deaths in the Phase Ib/II STAR-CNS study.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
FDA advisers raised concerns regarding the efficacy and risk-benefit profile of Genentech’s Polivy as a first-line treatment for large B-cell lymphoma ahead of a March 9 advisory committee meeting.
It might seem like luck for a company to trip over a multi-billion dollar COVID treatment already lurking in its pipeline – but perhaps not so much when that company, Gilead, has been at the leading edge of antiviral R&D for decades.
On Tuesday, Curis, Inc. announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
