Rx Product News (September 2020)

FOSTEMSAVIR (RUKOBIA)MANUFACTURED BY: ViiV Healthcare

The FDA recently approved fostemsavir as a novel inhibitor for the treatment of HIV-1 infection in heavily treatment-experienced adults with a multidrug-resistant HIV-1 infection or who are unable to use other medications. After 24 weeks of fostemsavir and other antiretroviral drugs, 53% of participants achieved HIV RNA suppression, according to the results of the phase 3 BRIGHTE study. The most common adverse effects were diarrhea, fatigue, and nausea, with 7% of participants having to discontinue fostemsavir at week 96 because of an adverse event.

FOR MORE INFORMATION: viivhealthcare.com

PEMBROLIZUMAB (KEYTRUDA)MANUFACTURED BY: Merck & Co

The FDA has approved pembrolizumab as a first-line treatment for unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer, making it the first single-agent, anti-programmed cell death protein 1 therapy approved in the first-line space for this patient population. In clinical trials, patients who received pembrolizumab had a more than double median progression-free survival, with a median duration of exposure of 11.1 months. Immunerelated adverse events can include colitis, hepatitis, nephritis, pneumonitis, and renal dysfunction.

FOR MORE INFORMATION: keytruda.com

AVELUMAB (BAVENCIO)MANUFACTURED BY: Pfizer/Merck KGaA

Patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy have a new immunotherapy treatment available with the recent approval of avelumab for this population. The drug is a PD-L1 antibody that engages both the adaptive and innate immune functions. In clinical trials with PD-L1—positive patients, investigators observed a 44% reduction in the risk of death among patients who received avelumab. A fatal adverse event (AE) occurred in 1 patient, and serious AEs occurred in 28% of patients receiving avelumab.

FOR MORE INFORMATION: pfizer.com

PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE INJECTION (PHESGO)MANUFACTURED BY: Genentech

A fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase for injection has received FDA approval to treat patients with metastatic HER2-positive breast cancer and patients with early HER2-positive breast cancer, as selected based on an FDA-approved companion diagnostic test. A noninferiority study found that the combination treatment has comparable efficacy and safety as intravenous pertuzumab and intravenous trastuzumab, except for administration-related reactions, which were higher with the combination because of the subcutaneous route of administration.

FOR MORE INFORMATION: gene.com