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FDA Extends Five Indications of Anticancer Agents in November

In November 2017, the United States Food and Drug Administration (FDA) issued new indications for five previously approved anticancer agents.

  • Adjuvant Sunitinib Approved in Renal Cell Carcinoma. The FDA expanded the indication of sunitinib (Sutent®, Pfizer) in renal cell carcinoma (RCC) to include use as adjuvant therapy following nephrectomy in patients at high risk for recurrence. This approval was based on the randomized phase III S-TRAC trial of 615 patients with high-risk clear cell RCC following nephrectomy. Treatment with adjuvant sunitinib resulted in a 1.2-year improvement in disease-free survival (DFS) compared to placebo (6.8 years vs 5.6 years; HR 0.76, P = .03). After five years there was no difference in overall survival, but data are not yet mature. The adverse event (AE) profile was tolerable and similar to that observed with sunitinib in advanced disease. The most common grade 3/4 AEs were erythrodysesthesia (16%), neutropenia (8.5%), hypertension (7.8%), and thrombocytopenia (6.2%). Sunitinib is the first adjuvant treatment to be approved for RCC.
  • Approval of Alectinib Expanded to First-Line for ALK-Positive NSCLC. The indication for the anaplastic lymphoma kinase (ALK)–targeting tyrosine kinase inhibitor (TKI) alectinib (Alecensa®, Genentech) was extended to include use in previously untreated patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). This decision was based on results from the randomized phase III ALEX study (N = 303), where alectinib treatment resulted in a 47% reduction in the risk of progression or death compared to crizotinib in previously untreated, patients with ALK-positive disease (HR 0.53, P<.0001). 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 a more favorable toxicity profile than crizotinib. More details regarding alectinib and the ALEX study can be seen in our prIME LINES coverage from the American Society of Clinical Oncology 2017 Annual Meeting. The FDA also converted alectinib’s accelerated approval to full approval for patients who are pretreated with crizotinib.
  • First-Line Obinutuzumab Combination for Follicular Lymphoma. Obinutuzumab (Gazyva®, Genentech) was granted full approval for use in previously untreated patients with bulky stage II-IV follicular lymphoma (FL), in combination with chemotherapy, followed by obinutuzumab monotherapy in responding patients. Approval was based on results from the randomized phase III GALLIUM trial that included patients with previously untreated indolent non-Hodgkin lymphoma, including 1202 patients with FL. In these patients, obinutuzumab plus chemotherapy followed by obinutuzumab maintenance significantly improved progression-free survival compared to rituximab plus chemotherapy followed by rituximab maintenance (HR 0.72, P = .0118).
  • Dasatinib Approved for Use in Pediatric Patients With CML. The FDA expanded the indication for dasatinib (Sprycel®, Bristol-Meyers Squibb), a BCR-ABL TKI, to include use in pediatric patients with Philadelphia chromosome (Ph)–positive chronic phase chronic myeloid leukemia (CML). Dasatinib is an established standard of care for adult patients with chronic phase CML. The expansion to pediatric patients was based on two studies that examined the safety and efficacy of dasatinib in a total of 97 pediatric patients. In both newly diagnosed and previously treated patients, dasatinib was associated with rapid and durable responses. At more than four years follow-up, over half of responding patients had not progressed. The AE profile of dasatinib in pediatric patients was consistent with that observed in adult patients.
  • Brentuximab Vedotin Now Available for Cutaneous Lymphomas. The CD30-targeting antibody drug conjugate (ADC) brentuximab vedotin (Adcetris®, Seattle Genetics) received approval for use in previously treated patients with primary cutaneous anaplastic large cell lymphoma and CD30-positive mycosis fungoides. This approval is based on results from the phase III ALCANZA trial involving 131 patients and two smaller phase II trials. In the ALCANZA trial, brentuximab vedotin significantly improved the rate of objective response lasting at least four months (ORR4) compared to physician’s choice of methotrexate or bexarotene therapy (56.3% vs 12.5%; P<.001). The most common AEs were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia, all occurring in less than 20% of patients.

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