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2022 FDA Drug Approvals | US Pharma News | iPharmaCenter

Updated: Mar 3


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.

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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

Tzield approved for delaying Stage 3 T1D in adults and pediatrics with Stage 2 T1D