Recent Drug Approvals Offer New Options for Non-Small Cell Lung Cancer, Genitourinary Cancers, and More
Cancer treatment options continue to multiply as 2017 continues, with the U.S. Food and Drug Administration (FDA) granting multiple new drug approvals and broadening indications for others. Oncology clinicians and nurses are challenged with staying abreast of treatment option expansions and navigating the dynamic field of cancer treatment to effectively navigate their patients through the treatment trajectory, educating on vital points relative to treatment, minimizing morbidity and mortality, and optimizing quality of life. Following is an overview of the latest approvals for the second quarter of 2017.
Non-Small Cell Lung Cancer (NSCLC)
Osimertinib for epidermal growth factor receptor and T790 mutation-positive NSCLC
- For progression after tyrosine kinase inhibitor therapy
- Common side effects include diarrhea and skin and nail changes.
- Recommended dosing is 80 mg orally once a day.
Brigatinib for anaplastic lymphoma kinase (ALK)-positive NSCLC
- For patients previously treated with crizotinib
- Common side effects include nausea, diarrhea, and fatigue; serious respiratory symptoms occur, so patients should be monitored.
- Recommended dosing is 90 mg orally once daily for seven days, then increased to 180 mg daily if tolerated.
Ceritinib for anaplastic lymphoma kinase (ALK)-positive NSCLC
- For patients previously treated with or intolerant of crizotinib
- Common side effects include diarrhea, nausea, vomiting, and fatigue.
- Recommended dosing is 750 mg orally once daily.
Pembrolizumab with pemetrexed and carboplatin for metastatic nonsquamous NSCLC
- This is a new indication for an already approved checkpoint inhibitor.
- Side effects include fatigue, nausea, and immune-related adverse events.
- Dosing is 200 mg via IV every three weeks.
Dabrafenib plus trametinib for BRAF-V600E mutation
- This is the first drug approved for this mutation in metastatic NSCLC.
- Common side effects include fever, fatigue, nausea, vomiting, and diarrhea.
- Recommended dosing is dabrafenib 150 mg orally twice daily and trametinib 2 mg orally once daily.
Palbociclib for hormone receptor-positive, human epidermal growth factor receptor-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor
- This represents an extended indication for palbociclib.
- Monitoring blood counts is recommended because neutropenia and infection are commonly seen with palbociclib.
- Recommended dosing is 125 mg orally once daily for 21 days in a 28-day cycle.
Avelumab for locally advanced or metastatic urothelial carcinoma
- Extended indication of this PD-L1 checkpoint inhibitor for use after platinum-based chemotherapy
- Dosing and supportive care are similar to other indications for avelumab.
Durvalumab for locally advanced or metastatic urothelial carcinoma
- A PD-L1 checkpoint inhibitor for use after platinum-based chemotherapy
- Common side effects include fatigue, musculoskeletal pain, constipation, and immune-related adverse events, including pneumonitis, colitis, and thyroid disorders.
- Recommended dosing is 10 mg/kg via IV every two weeks.
Pembrolizumab for locally advanced or metastatic urothelial carcinoma
- New indication for an already approved checkpoint inhibitor for those who’ve progressed after platinum-containing chemotherapy
- Dosing and adverse events are similar to other indications.
Regorafenib for hepatocellular carcinoma
- Patients must have had previous sorafenib therapy.
- Common side effects include pain, hand/foot reactions, fatigue, and diarrhea.
- Recommended dosing is 160 mg orally once a day.
Niraparib for recurrent ovarian and fallopian cancers and primary peritoneal cancer
- For patients who have had a complete or partial response after platinum-based chemotherapy
- Common side effects include myelosuppression, palpitations, nausea and vomiting, and constipation.
- Recommended dosing is 300 mg orally once a day.
Midostaurin for Flt3-positive acute myeloid leukemia
- Used in combination with cytarabine/daunorubicin induction and standard cytarabine consolidation
- Common side effects include febrile neutropenia, nausea, and mucositis.
- Dosing continues beyond induction and consolidation.
Rituxan hycela for follicular lymphoma, diffuse large B cell lymphoma, and chronic lymphocytic lymphoma
- Administered as a subcutaneous injection of combination rituximab and hyaluronidase
- Patients should have already received one full dose of IV rituximab.
- Side effects include infection, neutropenia, and nausea.
Premedicate with antihistamine and acetaminophen.
Avelumab for metastatic merkel cell carcinoma
- Avelumab is a PD-L1 checkpoint inhibitor.
- Common side effects are fatigue and immune-related adverse events, including pneumonitis, hepatitis, colitis, hypothyroidism, and hyperthyroidism.
- Recommended dosing is 10 mg/kg every two weeks with antihistamine and acetaminophen prior to first four cycles.
Trends in new approvals indicate that genetic and mutation testing is becoming an integral component in planning treatment. Decisions will heavily rely on antigens and mutations expressed by tumor cells, and oncology nurses will need to understand mutations common in certain cancer types and testing implications.