Oncology Practice Management Issues

April 2019, Vol 9, No 4

The Practice of Pharmacy in Medical Settings: A Ticking Time Bomb

Dawn Holcombe, MBA, FACMPE, ACHE

From the Editor

Physicians order, dispense, and administer medications under the scope of their medical license, approved by the Board of Medicine in the state where they practice. In oncology, this drug management usually involves the acquisition, transport, storage, handling, reconstitution, mixing, and administration of nonhazardous and hazardous drugs in their offices. Many physicians also dispense drugs that patients take home; this may be under the scope of a medical license or a pharmacy license, depending upon state laws. [ Read More ]

Adjuvant Therapy with Durvalumab, a Checkpoint Inhibitor, Shows Promise in Advanced Esophageal Cancer

Wayne Kuznar


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. Historically, the 1-year relapse rate has been 50% in patients with GEJ carcinoma who do not achieve a pathologic complete response with trimodal therapy, even with additional chemotherapy, said Hirva Mamdani, MD, Medical Oncology, Karmanos Cancer Institute/Wayne State University, Detroit, MI, at the 2019 Gastrointestinal Cancers Symposium. [ Read More ]

Triple-Drug Regimen Improves Survival in Metastatic Colorectal Cancer with BRAF V600E Mutation

Wayne Kuznar

Colorectal Cancer

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 More ]

MURANO: Venetoclax–Rituximab at Fixed Duration Beats Chemo­immunotherapy in Relapsed/Refractory CLL

Phoebe Starr


A 2-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 More ]

Lonsurf Now Indicated for Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

FDA Approvals, News & Updates

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 More ]

Herceptin Hylecta a New Subcutaneous Injection Approved for Patients with HER2-Positive Breast Cancer

FDA Approvals, News & Updates

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. This SC injection is a new formulation of intravenous (IV) trastuzumab. [ Read More ]

Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

FDA Approvals, News & Updates

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 More ]