FDA’s Latest Approved Drugs and Indications Include Two Oral Agents

Assessing oral adherence, encouraging patients to report adverse events, and ensuring their understanding of complex dosing regimens are critical components of nursing care. ONS offers an oral adherence toolkit (https://www.ons.org/toolkits/oral-adherence-toolkit) and oral chemotherapy patient education sheets (https://www.ons.org/toolkits/oral-chemotherapy-education-sheets) to help with patient management. 

Following is a summary of FDA approvals for new agents and indications in the cancer setting for the first part of 2019. As always, refer to the package insert for the most up-to-date dosing recommendations and administration considerations. 

Breast Cancer

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta^™) for HER2-positive breast cancer (https://voice.ons.org/news-and-views/fda-approves-trastuzumab-and-hyaluronidase-oysk-injection-for-subcutaneous-use)

• The new combination therapy represents a subcutaneous formulation of trastuzumab for HER2-expressing breast cancer.
• Dosing recommendations 600 mg trastuzumab/10,000 units hyaluronidase subcutaneously over two to five minutes once every three weeks. 
• The total volume may be more than what healthcare provider are accustomed to in a subcutaneous injection; however, the hyaluronidase component facilitates reabsorption. 
• Common adverse events include fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory infections, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and extremity pain.
• For more information about the combination therapy, see the article Oncology Drug Reference Sheet: Combination Trastuzumab and Hyaluronidase-Oysk (https://voice.ons.org/news-and-views/oncology-drug-reference-sheet-combination-trastuzumab-and-hyaluronidase-oysk).

Atezolizumab (Tecentriq^®) for PD-L1 positive locally advanced (https://voice.ons.org/news-and-views/fda-approves-atezolizumab-for-extensive-stage-small-cell-lung-cancer) or metastatic triple-negative breast cancer

• The approval is based on combination administration with protein-bound paclitaxel. Patients must be positive for PD-L1 expression.
• Dosing recommendations are based on a 28-day cycle. Administer atezolizumab 840 mg via IV over 60 minutes on days 1 and 15, followed by 100 mg/m² protein-bound paclitaxel on days 1, 8, and 15. 
• Adverse events include alopecia, peripheral neuropathy, fatigue, nausea, diarrhea, and anemia.  

Gastrointestinal Cancers

Trifluridine and tipiracil (Lonsurf^®) for recurrent metastatic gastric or gastroesophageal junction adenocarcinoma (https://voice.ons.org/news-and-views/fda-approves-trifluridine-and-tipiracil-tablet)

• The approval is based on study results in which subjects demonstrated improvements in progression-free survival.
• Patients must have completed at least two prior lines of chemotherapy. 
• Dosing schedule is complex and will require education and monitoring for adherence. Current recommendation is 35 mg/m² orally twice a day with food on days 1–5 and 8–12 of a 28-day cycle. 
• Adverse events include myelosuppression, nausea, decreased appetite, vomiting, and diarrhea.   

Hepatocellular Carcinoma 

Cabozantinib (Carometyx^®) for patients with hepatocellular carcinoma previously treated with sorafenib (https://voice.ons.org/news-and-views/fda-approves-cabozantinib-for-hepatocellular-carcinoma)

• Clinical trial results demonstrated improved progression-free survival and overall response rate compared to patients in the noncabozantinib arm. 
• Cabozantinib is administered at 60 mg orally once daily on an empty stomach.
• The most frequently cited adverse events were diarrhea, fatigue, decreased appetite, and nausea.

Lung Cancer 

Atezolizumab in combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (https://voice.ons.org/news-and-views/fda-approves-atezolizumab-for-extensive-stage-small-cell-lung-cancer)

• FDA’s approval is based on atezolizumab administered in combination with carboplatin and etoposide. 
• The recommended dose is 1,200 mg via over 60 minutes every three weeks. If atezolizumab is administered on the same day chemotherapy, atezolizumab should be administered first.
• The most common adverse events are fatigue/asthenia, nausea, alopecia, constipation, and decreased appetite.   

Melanoma

Pembrolizumab (Keytruda^®) for adjuvant therapy (https://voice.ons.org/news-and-views/fda-approves-pembrolizumab-for-adjuvant-treatment-of-melanoma)

• The approval was based on clinical trial data that showed fewer deaths and recurrences in the pembrolizumab arm versus the placebo arm. Subjects completed successful resection and radiotherapy if indicated within 13 weeks of trial initiation. 
• The recommended dosing is 200 mg given via IV over 30 minutes every three weeks.
• Adverse events noted were similar to those of other documented cases involving pembrolizumab and included diarrhea, pruritis, nausea, arthralgia, and hypothyroidism.