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Gilead Sciences' Bixlenvo Approved by FDA for HIV Treatment

Gilead Sciences announced that the FDA approved Bixlenvo - bictegravir 75 mg/lenacapavir 50 mg -, the smallest once-daily single tablet regimen for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals. The FDA approval is based on results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials. In both trials, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified. Detailed ARTISTRY-1 results were published in The Lancet, and ARTISTRY-2 results were published in Lancet HIV. Bictegravir and lenacapavir in combination are not approved by any regulatory authority outside of the U.S.

Lakefront Biotherapeutic Receives FDA Orphan Drug Designation

Lakefront Biotherapeutic (LKFT) announced that the FDA has granted orphan drug designation to gamgertamig for the treatment of pemphigus. Gamgertamig was previously granted both Fast Track and Orphan Drug Designation by the FDA for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia. Gamgertamig is being developed by Lakefront in collaboration with Gilead (GILD). Ongoing clinical trials in autoimmune diseases are actively enrolling, and expansion of the clinical trials program is anticipated in 2027.

Gilead Sciences' Trodelvy and Keytruda Combo Approved by EU

Gilead Sciences announced that the European Commission has granted marketing authorization for Trodelvy in combination with Keytruda for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score. Trodelvy plus Keytruda is the first and only antibody-drug conjugate plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union's 27 member states, as well as Norway, Iceland and Liechtenstein.