Recent FDA Approvals Continue to Focus on Targeted and Immunotherapy

Five cancer-related U.S. Food and Drug Administration (FDA) approvals occurred in the first quarter of 2017; following are their indications for treatment and associated clinical implications. (Refer to the package inserts to guarantee the most recent dosing and drug information.) You’ll recognize that some of the agents were already FDA approved for other uses, but as clinical trials continue and new data emerge, clinical use is expanding to other disease sites and indications.

Nivolumab for metastatic bladder cancer

• Dosing is the same as for other disease site indications: 240 mg via IV every two weeks.
• Patients must have received prior platinum-based chemotherapy.
• The most commonly reported adverse events include fatigue, musculoskeletal pain, nausea, and decreased appetite.

Lenalidomide for maintenance therapy in multiple myeloma

• Maintenance dosing is 10 mg/day orally.
• Myelosuppression is the most commonly experienced side effect, with more than half of clinical trial subjects experiencing grade 3 or 4 neutropenia
• This approval makes lenalidomide the only approved agent for maintenance therapy after autologous stem cell transplant for patients with multiple myeloma.

Telotristat ethyl for treatment of adults with carcinoid syndrome diarrhea

• Although rare, carcinoid tumors are found along the GI tract and result in uncontrolled diarrhea, weight loss, malnutrition, and dehydration.
• Telotristat ethyl, a serotonin inhibitor, is taken orally three times a day.
• Approval is based on combining telotristat ethyl with somatostatin analog.
• Side effects include nausea, headaches, depression, and peripheral edema.
• Constipation can occur and be quite serious, so patients should be monitored closely.

Ribociclib in combination with aromatase inhibitors for HR-postivie/HER2-negative or metastatic breast cancer

• Dosing is 600 mg orally once daily for 21 days of a 28-day cycle.
• Ribociclib is a targeted agent, specifically a cyclin-dependent kinase 4/6 inhibitor.
• Common side effects include neutropenia, nausea, fatigue, diarrhea, alopecia, constipation, headache, and back pain.

Pembrolizumab for refractory classical Hodgkin lymphoma in the adult and pediatric settings

• Dosing is 200 mg every three weeks in adults and 2 mg/3 kg every two weeks for pediatric patients.
• Pembrolizumab is a PD-1 inhibitor associated with fatigue, fever, cough, musculoskeletal pain, diarrhea, rash, elevated liver function tests, and other immune-related adverse events.
• Use with caution in patients who may undergo allogeneic stem cell transplant.