December 23, 2022
FDA approved Lunsumio, Roche's bispecific antibody, for follicular lymphoma
Roche announced that its bispecific antibody Lunsumio (mosunetuzumab) was approved for treating relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
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The approval was based on the pivotal phase II GO29781; an open-label dose-escalation study aimed to evaluate Lunsumio in patients with relapsed or refractory B-cell non-Hidgkin lymphoma. In patients who received at least two previous treatments, 80% achieved durable response rates, with 60% achieving complete remission.
Lunsumio has received accelerated approval based on the response rate. Complete approval will be based on the clinical benefit demonstrated in the confirmatory trial. Lunsumio is a CD20xCD3 T-cell engaging bi-specific antibody administered in fixed duration for cancers.
Follicular lymphoma is a common slow-growing cancer, a form of non-Hodgkin lymphoma. In 2022, in the US, nearly 13,000 new cases of follicular lymphoma were diagnosed.
December 22, 2022
Gilead received approval for its twice-yearly HIV treatment Sunlenca.
Gilead announced that the US Food and Drug Administration approved Sunlenca (lenacapavir), a twice-yearly treatment for treating multi-drug resistant human immunodeficiency virus infection.
Sunlenca is a capsid inhibitor, given in combination with other antivirals (ARV), and is approved for heavily treatment-experienced HIV patients. There is no cross-resistance reported with existing classes of HIV therapies.
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The approval was based on the Phase 2/3 CAPELLA trial, in which Sunlenca was tested in combination with a background regimen. At week 52, 83% of patients administered Sunlenca plus background therapy achieved an undetectable viral load.
Sunlenca received Breakthrough Therapy Designation for treating HIV-1 infection.
November 17, 2022