Tag Archive for: follicular lymphoma

Epkinly is now the “first and only” T-cell-engaging bispecific antibody for the subcutaneous treatment of relapsed or refractory follicular lymphoma, according to the companies.

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.

Yesterday the agency ranted accelerated approval to BeiGene’s BTK inhibitor Brukinsa (zanubrutinib), when used in combination with Genentech’s Gazyva (obinutuzumab), to treat patients with relapsed or refractory follicular lymphoma who have undergone at least two lines of systemic therapy.

The response rate exceeded the prespecified efficacy threshold and suggests epcoritamab may hold its own against Roche’s rival CD3xCD20 bispecific Lunsumio, which won FDA approval in follicular lymphoma last year.

The U.S. health regulator has approved Roche Holding AG’s therapy for treating a type of rare cancer called follicular lymphoma.

AstraZeneca is strengthening its oncology pipeline with the acquisition of TeneoTwo, which has an ongoing Phase I trial in relapsed and refractory B-cell non-Hodgkin lymphoma, in a deal valued at up to $1.27 billion. 

The long weekend saw three established drugs developed by Bristol Myers Squibb, Novartis, and Roche score new approvals from the U.S. Food and Drug Administration.