The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The FDA has approved Phesgo™ (pertuzumab, trastuzumab, hyaluronidase-zzxf; Genentech), in combination with chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.
The FDA has granted accelerated approval of Xpovio® (selinexor; Karyopharm) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Tazverik, a methyltransferase inhibitor, is already indicated for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
The FDA has approved Crysvita® (burosumab-twza; Ultragenyx) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in patients aged ≥2 years.
he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.
The FDA has approved an expanded indication for Gardasil 9® (human papillomavirus 9-valent vaccine [HPV], recombinant; Merck) to include the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 in patients aged 9 to 45 years.
The FDA has approved Opdivo® (nivolumab; Bristol Myers Squibb) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Nyvepria is expected to be available in late 2020.
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
