Brian Park, PharmD

The FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel; Kite Pharma) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

In the CRL, the FDA stated that the data from KEYNOTE-524/Study 116 did not demonstrate a meaningful advantage over available therapies for unresectable or metastatic HCC.

The administration of cedazuridine with decitabine prevents the degradation of decitabine by CDA in the gastrointestinal tract and liver increasing its systemic exposure.

Helsinn and MEI Pharma have discontinued a phase 3 study evaluating pracinostat, in combination with azacitidine, for frontline treatment of older patients with acute myeloid leukemia.

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 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 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 accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H who were enrolled in the open-label phase 2 KEYNOTE-158 trial.

The FDA has expanded the approval of Mylotarg (gemtuzumab ozogamicin; Pfizer) to include treatment of patients aged 1 month and older with newly-diagnosed CD33-positive acute myeloid leukemia.