Adcetris

Seagen Inc. (Nasdaq: SGEN) has announced that the U.S. Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Originally approved by the FDA on August 19, 2011, Adcetris (brentuximab vedotin) injection is a CD30directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and mycosis fungoides. 5 Drug News – Volume 9, Issue 12

Libtayo

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology. Originally approved by the FDA on September 28, 2018, Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

Rotarix

GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has approved an oral-dosing applicator-only presentation (liquid formulation) of Rotarix (Rotavirus Vaccine, Live, Oral), which prevents rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4 and G9) in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare Rotarix by removing the need to reconstitute the vaccine dose at the point of use. 6 Drug News – Volume 9, Issue 12 Originally approved by the FDA on April 3, 2008, Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.