Cabenuva (cabotegravir, rilpivirine), Vocabria (cabotegravir) – New drug approvals
The FDA announced the approval of ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Lupkynis™ (voclosporin) – New drug approval
Aurinia Pharmaceuticals announced the FDA approval of Lupkynis (voclosporin), in combination with a background immunosuppressive therapy regimen, for the treatment of adult patients with active lupus nephritis (LN).
Verquvo™ (vericiguat) – New drug approval
Merck announced the FDA approval of Verquvo (vericiguat), to reduce the risk of cardiovascular (CV) death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.
Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication, expanded indication
Janssen announced the FDA approval of Darzalex Faspro (daratumumab/hyaluronidase-fihj), in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
Daiichi Sankyo and AstraZeneca announced the FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki), for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Opdivo® (nivolumab), Cabometyx® (cabozantinib) – Expanded indication
Bristol Myers Squibb and Exelixis announced the FDA approval of Opdivo (nivolumab) plus Cabometyx (cabozantinib), for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Xalkori® (crizotinib) – New indication
Pfizer announced the FDA approval of Xalkori (crizotinib), for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.