Four Oncology Agents Approved in the United States in February

  • Abemaciclib Indication Expanded to Include Previously Untreated Metastatic Breast Cancer. Abemaciclib (Verzenio®, Eli Lilly and Company), a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, was approved for use in combination with an aromatase inhibitor (AI) for first-line treatment of postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer. This Food and Drug Administration (FDA) approval is a combination of abemaciclib (150 mg orally twice daily) and nonsteroidal AI resulted in a 28.2 month progression-free survival (PFS), compared to 14.8 months with AI alone (HR 0.54, P<.0001). Abemaciclib was previously approved in combination with fulvestrant for patients with HR-positive, HER2-negative metastatic breast cancer who had progressed on endocrine therapy and as monotherapy for those who progressed following endocrine therapy and prior chemotherapy.
  • Durvalumab Gets Green Light for Use After Chemoradiation in Locally Advanced NSCLC. On 16 February, the PD-L1 inhibitor durvalumab (Imfinzi®, AstraZeneca) became the first immunotherapy approved for treatment of patients with stage III, unresectable, non-small cell lung cancer (NSCLC) whose cancer has not progressed after chemoradiation. The approval was based on results from the randomized phase III PACIFIC trial. Durvalumab treatment was associated with a median PFS of 16.8 months, compared to 5.6 months with placebo (HR 0.52, P<.0001). Adverse events (AEs) were consistent with the known safety profile of durvalumab, including a risk for serious immune-mediated AEs.
  • Apalutamide First Approved Treatment for Nonmetastatic CRPC. The FDA approved the nonsteroidal androgen receptor inhibitor apalutamide (Erleada®, Janssen) for treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC). In the pivotal phase III SPARTAN trial, apalutamide (240 mg orally once daily) plus androgen deprivation therapy (ADT) reduced the risk of progression or death by 72% compared to ADT alone, with a median metastasis-free survival improvement of 24.3 months (40.5 months vs 16.2 months; HR 0.28, P<.0001). Apalutamide is the first FDA-approved treatment for nonmetastatic CRPC, which has historically been associated with poor prognosis and rapid progression to metastatic disease. The AEs associated with apalutamide were mostly mild and easily managed.
  • FDA Gives Okay for Abiraterone for Castration Sensitive Prostate Cancer. The indication of abiraterone acetate (Zytiga®, Janssen) was expanded to include use in combination with prednisone for treatment of high-risk castration-sensitive prostate cancer. Abiraterone has previously been approved for treatment of patients with CRPC, both before and after chemotherapy. Approval in patients with castration-sensitive disease was based on results from the international phase III LATITUDE study, in which daily abiraterone (1000 mg orally once daily) and prednisolone (5 mg once daily) was associated with a significant improvement in overall survival (OS) compared to placebo (not reached vs 34.7 months; HR 0.621, P<.0001) in patients undergoing ADT. Patients treated with abiraterone should receive either a gonadotropin-releasing hormone analog concurrently or have had bilateral orchiectomy.
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