April 2019, Vol 9, No 4

On February 22, 2019, the FDA approved a new indication for triflur­idine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoro­pyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy. Read Article ›

On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the ad­­juvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality anthracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. Read Article ›

On March 1, 2019, the FDA accelerated the approval of atezoliz­umab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC. Read Article ›

On April 4, 2019, the FDA approved a new indication for palbociclib (Ibrance; Pfizer), an oral kinase inhibitor, for men with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer. Read Article ›

A chimeric antigen receptor (CAR) T-cell therapy that targets CD19 and CD22 molecules has demonstrated safety and efficacy, in patients with relapsed or refractory B-cell precursor acute lymphoblastic lymphoma (ALL), with response rates consistent with CAR T-cell therapies that target CD19 alone. Read Article ›

On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin. Read Article ›

A2-year duration of combination immunotherapy with ven­etoclax (Venclexta) and rituximab (Ri­tuxan) improved survival compared with standard-of-care chemoimmunotherapy combination with bendamustine (Ben­deka) plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to follow-up data from the MURANO clinical trial presented at ASH 2018. Early results were first presented at ASH 2017. Read Article ›

Updated results from the safety lead-in of the phase 3 BEACON CRC clinical trial show a mature median overall survival (OS) of 15.3 months with the triple-drug regimen of encorafenib (Braftovi), a BRAF inhibitor; binimetinib (Mektovi), a MEK inhibitor; and cetuximab (Erbitux), an epidermal growth factor receptor (EGFR) inhibitor, for the treatment of patients with metastatic colo­rectal cancer (CRC) and BRAF V600E mutation. Read Article ›

Selinexor has shown promising activity in very heavily pretreated patients with penta­refractory multiple myeloma. In the pivotal STORM Part 2 study, oral selinexor in combination with low-dose dexamethasone induced responses in 26.2% of patients. Read Article ›

Adjuvant treatment with durvalumab (Imfinzi), a checkpoint inhibitor, in patients with residual disease after trimodal therapy for advanced esophageal or gastroesophageal junction (GEJ) adenocarcinoma was associated with a 79% 1-year relapse-free survival rate in a phase 2 clinical trial. Read Article ›