EMA Gives Green Light to Three Oncology Agents in October

On 12 October 2017, the European Medicines Agency (EMA) issued positive opinions supporting approval of expanded indications for three oncology treatments.

  • Alectinib for First-Line Therapy of ALK-Rearranged Lung Adenocarcinoma. The anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alecensa®, Roche) was previously approved only for ALK-positive patients who had progressed on crizotinib. The EMA recommendation to extend indication to first-line therapy is based on robust results from the randomized phase III ALEX trial, which is the first trial to compare the next-generation ALK inhibitor alectinib to the first-generation inhibitor crizotinib in previously untreated patients with advanced ALK-positive non-small cell lung cancer (NSCLC). In this trial, alectinib was associated with a 53% reduction in the risk of disease progression or death compared to crizotinib (HR 0.47; P<.001). Results of PFS assessed by independent review committee were consistent with investigator assessment, confirming a significant 15-month improvement of PFS with alectinib. Alectinib was also significantly more effective than crizotinib in preventing and treating brain metastases (HR 0.16, P<.001). In addition, alectinib was associated with more favorable toxicity profile than crizotinib.
  • Abiraterone for Newly Diagnosed High-Risk Metastatic Hormone-Sensitive Prostate Cancer. Abiraterone acetate (Zytiga®, Janssen-Cilag) received positive opinion for use in combination with androgen deprivation therapy (ADT) in men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer. This recommendation is based on results from the large randomized, double-blind and placebo-controlled phase III LATITUDE study, which showed that the addition of abiraterone to ADT was associated with an improved rate of overall survival (OS), and a 38% reduction in risk of death. Further results from this study can be found in our prostate cancer coverage from the 2017 American Society of Clinical Oncology annual meeting. Abiraterone has previously been approved for use in men with metastatic castration-resistant prostate cancer either before or after docetaxel chemotherapy.
  • Fulvestrant and Palbociclib Combination for Breast Cancer. The recommended expansion of indication for fulvestrant (Faslodex®, AstraZeneca) includes use in combination with the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor palbociclib in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who have previously been treated with endocrine therapy. This is based on positive results of the phase III PALOMA-3 trial, in which the combination resulted in a 4.9-month improvement in PFS (HR 0.46, P<.0001) compared to single-agent fulvestrant. In premenopausal women, fulvestrant and palbociclib should be given in combination with a luteinizing hormone releasing hormone (LHRH) agonist.


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