FDA Approved Three New Oncology Indications in January

  • Olaparib Given Greenlight in BRCA-Mutated Breast Cancer. The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza®, AstraZeneca) was approved for use in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy and, if appropriate, a hormonal therapy. This approval was based on results from the phase III OlympiAD trial, in which olaparib resulted in a 42% reduction in the risk of progression or death compared to physician’s choice of chemotherapy in patients with BRCA-positive breast cancer. Olaparib was associated with a 7.0 month PFS, compared to 4.2 months with chemotherapy (HR 0.58, P = .001). The adverse event (AE) profile was consistent with the known safety profile of olaparib. This is the first PARP inhibitor approved for treatment of BRCA-mutated metastatic breast cancer. Concurrent with the olaparib approval, the indication of the BRACAnalysis CDx genetic test was expanded to include patients with breast cancer.
  • Expanded Indication for Afatinib in NSCLC. The indication for afatinib (Gilotrif®, Boehringer Ingelheim), an epidermal growth factor receptor (EGFR) inhibitor, in non-small cell lung cancer (NSCLC) was expanded to include first-line treatment of patients with uncommon, nonresistance EGFR mutations (L861Q, G719X, or S768I). This decision was based on durable responses in a subset of 32 patients with these mutations treated with afatinib across the phase II LUX-Lung 2 and phase III LUX-Lung 3 and LUX-Lung 6 trials. Patients with uncommon EGFR mutations treated with afatinib on these trials had an objective response rate (ORR) of 66%, and 52% of responses lasted longer than 12 months. Afatinib was previously approved in NSCLC for treatment of patients with EGFR exon 19 deletions or exon 21 substitutions and for metastatic squamous cell NSCLC progressing after platinum-based chemotherapy.
  • Lu-177 dotatate: New Treatment for GEP– The Food and Drug Administration (FDA) approved lutetium (Lu-177) dotatate (Lutathera®, Advanced Accelerator Applications USA), a radiolabeled somatostatin analog, for treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the phase III NETTER-1 trial, Lu-177 reduced the risk of progression or death by 79% compared to high-dose octreotide in patients with grade 1 or grade 2 metastatic midgut NETs who had progressed on standard-dose octreotide. Treatment-related AEs occurred in 86% of patients treated with Lu-177, and 5 patients discontinued treatment due to AEs. The rates of grade 3/4 AEs with Lu-177 were similar as with high-dose ocetreotide LAR. However, only patients receiving Lu-177 dotatate had transient grade 3/4 neutropenia, thrombocytopenia and lymphopenia in 1%, 2%, and 9%, respectively. Of note, there was no evidence of renal toxicity.

 

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