Epkinly (epcoritamab) is a subcutaneously delivered CD3×CD20 BiTE that secured FDA accelerated approval in 2023 for r/r DLBCL.
Merck has commenced the Phase III waveLINE-010 trial to assess its investigational antibody-drug conjugate (ADC), zilovertamab vedotin, combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP), to treat individuals with previously untreated diffuse large B-cell lymphoma (DLBCL).
With the positive results of the waveLINE-007 trial, Merck and Co. is planning a Phase III trial in first-line DLBCL.
Roche has released data from the Phase III STARGLO trial where its therapy Columvi (glofitamab) plus gemcitabine plus oxaliplatin (GemOx) improved overall survival (OS) in relapsed or refractory (R/R) DLBCL patients.
In the oncology space, drug developers are keen to develop cutting-edge solutions—and lay claim to a piece of a market estimated to hit $359.1 billion by 2028. However, most Phase III trials fail to present significant clinical improvements on the standard of care.
"Oncology . . . is huge because there are some successes, but there’s still a huge medical need,” Ansbert Gadicke, managing partner at MPM BioImpact, told BioSpace earlier this year.
An FDA committee of outside cancer experts voted 11-2 Thursday that the FDA should expand Roche’s Polivy label to include it as a treatment in combo with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
The U.S. Food and Drug Administration (FDA) greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
Gilead and Novartis may soon face the first rival to their CAR-T therapies.
The FDA has accepted the BLA for Morphosys’s tafasitamab, an antibody that targets the same CD-19 antigen that CAR-T therapies do and looked in pivotal studies to be as or more effective. The agency gave it priority review and a PDUFA date of August 30, in-line with the company’s previous projections of a mid-2020 market launch.
Novartis announced results from two analyses of real-world experience with Kymriah (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications.