FDA Approves First Biosimilar for Cancer Treatment, Among Other New Immunotherapy Dosing and Indications
Cancer treatment options continue to multiply as 2017 concludes, with the U.S. Food and Drug Administration (FDA) granting additional new drug approvals and broadening indications for others. Checkpoint inhibitors continue to explode on the scene with accelerated approvals for various indications. Treatment options for hematologic cancers are multiplying. Additionally, the first biosimilar for cancer treatment, bevacizumab-awwb, was approved as a biosimilar to bevacizumab.
Biosimilar
- Bevacizumab-awwb for metastatic colorectal cancer, nonsquamous non-small cell lung cancer (NSCLC), glioblastoma, cervical cancer, and metastatic renal cancer
- Approvals for colorectal, NSCLC, and cervical cancers require it to be combined with other chemotherapy agents.
- Commons side effects include epistaxis, headache, hypertension, rhinitis, and proteinuria. More serious side effects include perforation or fistula.
Breast Cancer
- Neratinib for HER2+ breast cancer
- Intended adjuvant treatment after trastuzumab-based therapy.
- Recommended dosing is 240 mg orally daily.
- Most common adverse events are diarrhea, nausea, abdominal pain, and fatigue.
- Diarrhea prophylaxis is recommended.
Genitourinary Cancers
- Lower dose of cabazitaxel for prostate cancer
- The recommended dose is now 20 mg/m2 every three weeks, as opposed to earlier recommendations of 25 mg/m2.
- Myelosuppression remains a concern but was not experienced with as much frequency as the 25 mg/m2 arm.
- Other side effects include diarrhea, fatigue, nausea, and vomiting.
Gastrointestinal Cancers
- Nivolumab for metastatic colorectal cancer after fluoropyrimidine, oxaliplatin, and irinotecan
- Recommended dosing is 240 mg every two weeks.
- Common side effects include fatigue, rash, and immune-related adverse events.
- Accelerated approval of nivolumab for hepatocellular carcinoma
- Recommended dosing is 240 mg every two weeks.
- Side-effect profile remains consistent to other indications, including fatigue, rash, musculoskeletal pain, and immune-related adverse events.
- Accelerated approval of pembrolizumab for advanced gastric cancer
- Tumors should express PD-L1.
- Recommended dosing is 200 mg via IV over 30 minutes every three weeks.
- The side-effect profile remains consistent to other indications, including fatigue, musculoskeletal pain, and immune-related adverse events.
Gynecologic Cancers
- Olaparib for maintenance treatment for ovarian cancer after failed platinum-based chemotherapy
- Recommended dosing is 300 mg orally twice a day.
- Common adverse events include anemia, nausea, vomiting, and fatigue.
Hematologic Malignancies
- Blinatumomab for Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (ALL)
- Approval for blinatumomab was previously reserved for Philadelphia chromosome-negative ALL but is now being extended.
- No new side effects were added to the profile.
- Dexamethasone recommended for premedication.
- Inotuzumab ozogamicin for relapsed or refractory B-cell ALL
- Recommended dosing is 1.8 mg/m2 on days 1, 8, and 15 of each cycle.
- Adverse events include thrombocytopenia, infection, and anemia, and infection.
- Enasidenib for adults with relapsed or refractory AML with an IDH2 mutation
- Recommended dosing is 100 mg orally once a day.
- Common side effects are nausea, vomiting, and diarrhea.
- Differential syndrome is also a possibility, requiring immediate intervention.
- Ibrutinib for the treatment of chronic graft-versus-host disease
- Patients must have failed treatment with corticosteroids.
- Recommended dosing is 420 mg orally once a day.
- Common side effects include fatigue, bruising, diarrhea, and thrombocytopenia and may require dose reductions.
- Tisagenlecleucel for B-cell ALL
- This is the first FDA-approved chimeric antigen receptor T-cell immunotherapy.
- Engineered T-cells are reinfused after lymphodepleting chemotherapy.
- It targets leukemia cells with the CD19 antigen.
- A common adverse event is cytokine release syndrome.
- Liposome-encapsulated combination daunorubicin-cytarabine for acute myelogenous leukemia (AML)
- The two agents commonly used for up-front treatment for AML can be reconstituted and administered together.
- Dosing is performed over 90 minutes on days 1, 3, and 5, but second induction and consolidation dosing and schedule will vary.
- Common adverse events include hemorrhage, febrile neutropenia, rash, and edema.
- Gemtuzumab ozogamicin for CD33-positive AML
- Although previously approved for relapsed/refractory CD33-positive AML, it was removed from the market after concerns were raised about safety and clinical efficacy.
- Dosing will vary throughout the treatment cycle and according to goal of treatment.
- Copanlisib for adults with relapsed follicular lymphoma
- Recommended dosing is 60 mg via IV over one hours on days 1, 8, and 15 of a 28-day treatment cycle.
- Common adverse events include hyperglycemia, diarrhea, fatigue, and hypertension.
Some agents with highly optimistic outcomes are receiving fast-tracked FDA approval to increase access. Nurses must continue to report adverse events and side effects for on-label, FDA-approved agents available on the market. Clinicians are lacking more clinical trial data in these instances, and nurses are encouraged to inform the FDA of adverse events through the FDA MedWatch Reporting System (http://www.fda.gov/medwatch/report).