Four Oncology Indications Approved by FDA in January and February

  • Subcutaneous Trastuzumab Now Available in US for HER2- Positive Breast Cancer. The FDA approved trastuzumab and hyaluronidase-oysk injection (Herceptin Hylecta™, Genentech), a subcutaneous (SC) formulation of trastuzumab, for treatment of patients with HER2-positive breast cancer. Approval was based on results from the HannaH and SafeHER studies, which compared trastuzumab and hyaluronidase-oysk to standard intravenous (IV) trastuzumab and found similar rates of efficacy and safety for the two formulations. In patients with HER2-positive early breast cancer, SC trastuzumab resulted in a pathologic complete response (pCR) of 45.4%, which was noninferior to the 40.7% pCR rate in patients receiving IV trastuzumab. This formulation of trastuzumab has been approved in the European Union (EU) since 2013.
  • Adjuvant Pembrolizumab for Stage III Melanoma. The indication of the PD-1 inhibitor pembrolizumab (Keytruda®, Merck) was extended to include use as adjuvant therapy following complete resection in patients with high-risk stage III melanoma with involvement of the lymph nodes. This decision was based on results from the phase III KEYNOTE-054 trial, in which pembrolizumab reduced the risk of disease recurrence or death by 43% compared to placebo (HR 0.57, P<001) in patients with stage III melanoma. The approval of pembrolizumab in the adjuvant setting includes patients with stage IIIA disease, while nivolumab is only approved in this setting for stage IIIB/C disease.
  • Trifluridine/Tipiracil Approved for Gastric Cancer. The oral combination chemotherapy trifluridine/tipiracil (Lonsurf®, Taiho Pharmaceuticals), commonly called TAS-102, was approved for treatment of patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously received at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan. In the phase III TAGS trial, TAS-102 resulted in a 5.7-month median overall survival (OS) in patients with heavily pretreated gastric cancer, compared to 3.6 months with placebo (HR 0.69, P = .0003). Patients with HER2-expressing gastric cancer should receive a HER2-targeted treatment prior to treatment with TAS-102.
  • Cabozantinib, Another Approved Option for Progressive HCC. The FDA extended the indication of the angiogenesis inhibitor cabozantinib (Cabometyx®, Exelexis) to include use in patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. This decision was based on findings from the phase III CELESTIAL trial, in which cabozantinib resulted in a 2.2-month improvement in OS compared to placebo (10.2 months vs 8.0 months; HR 0.76, P = .0049), corresponding to a 24% reduction in the risk of progression or death. Cabozantinib was associated with an increased rate of grade 3-5 adverse events (AEs) compared to placebo, including higher rates of hand-foot syndrome.


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