It is becoming more commonplace for nurses to find orders for agents with which they are unfamiliar or quite possibly have never administered. Following is a summary of the latest new U.S. Food and Drug Administration (FDA) approvals or indications to keep you up to date in your practice. Of note, this summary contains the approval of yet another biosimilar in trastuzumab-dkst and rolapitant for chemotherapy-induced nausea and vomiting, which includes a safety alert. Early experiences with rolapitant, a NK-1 inhibitor, indicated a risk of hypersensitivity reactions. Additional details are provided below.

Biosimilar

Trastuzumab-dkst as a biosimilar to trastuzumab for patients with HER2-overexpressing breast or metastatic stomach cancer

  • Common side effects may depend on indication for the drug but include headache, diarrhea, nausea, chills, or stomatitis.
  • As with trastuzumab, clinicians must still monitor and assess for cardiomyopathy, infusion reactions, and pulmonary toxicity.

Breast Cancer

Olaparib for BRCA-mutated, HER2-negative metastatic breast cancer

  • Recommended dosing is 300 mg orally twice daily with or without food.
  • Common side effects include anemia, nausea, fatigue, vomiting, and neutropenia.

Lung Cancer

Alectinib for ALK-positive, metastatic non-small cell lung cancer (NSCLC)

  • Recommended dosing is 600 mg orally twice daily with food.
  • Common adverse events include fatigue, constipation, edema, myalgia, and anemia.

Afatinib for metastatic NSCLC expressing EGFR mutations

  • Recommended dosing is 40 mg orally daily.
  • Common side effects include diarrhea, rash, dermatitis, stomatitis, and paronychia.

Genitourinary Cancer

Sunitinib malate for adjuvant treatment of renal cell carcinoma following nephrectomy

  • Recommended dosing is 50 mg orally once daily with or without food.
  • Common adverse events include fatigue, diarrhea, mucositis, nausea, and decreased appetite.

Cabozantinib for first-line advanced renal cell carcinoma

  • This is an extended approval, making the agent approved for first-line therapy.
  • Recommended dosing is 60 mg orally.
  • Common side effects include hypertension, diarrhea, and hyponatremia.

Hematology

Brentuximab vedotin for primary cutaneous anaplastic large cell lymphoma or mycosis fungoides

  • Recommended dosing is 1.8 mg/kg (not to exceed 180 mg) over 30 minutes every three weeks.
  • Common adverse events include anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. Peripheral neuropathy was dose limiting in some instances. 

Dasatinib for pediatric chronic myeloid leukemia (CML)

  • Pediatric dosing is weight based.
  • Common adverse events include headache, nausea, diarrhea, and skin rash. Patient adherence has proven problematic with dasatinib for other indications. 

Obinutuzumab for follicular lymphoma

  • The drug is a tumor-targeting monoclonal antibody.
  • Recommended dosing is 1,000 mg on days 1, 8, and 15.  
  • Common adverse events include infusion reactions, neutropenia, upper respiratory tract infection, cough, and constipation.

Bosutinib for newly diagnosed Philadelphia chromosome-positive CML

  • Recommended dosing is 400 mg orally once daily with food.
  • Common side effects include diarrhea, nausea, thrombocytopenia, and rash.

Symptom Management and Supportive Care

Rolapitant for delayed chemotherapy-induced nausea and vomiting

  • The NK-1 inhibitor is administered in combination with a 5-HT3 receptor antagonist and dexamethasone up to two hours before chemotherapy begins. 
  • MedWatch alerts indicated that rolapitant is associated with hypersensitivity reactions. Rolapitant contains traces of soybean, and the manufacturer recommends obtaining an allergy history prior to administration. 

Two prominent themes emerge with the latest FDA approvals: (a) the growing implication of genomics and tumor testing on treatment decision making and (b) the role oral agents are playing in cancer treatment. Tumor markers and testing are critical in identifying appropriate treatment regimens, and nurses are critical to helping patients and their families understand the role of tumor testing. 

ONS’s Oral Chemotherapy Guide provides support and education for patients and caregivers on the challenges of oral therapy. Look for additional resources on genetics and genomics at www.ons.org throughout 2018.  

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