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Results from the phase 3 ARIEL3 clinical trial showed that maintenance therapy with rucaparib leads to significantly improved progression-free survival in patients with advanced ovarian cancer and non-BRCA homologous recombinant repair gene mutations.
At the 12-month landmark analysis of the single-arm phase 2 OVARIO clinical trial, 75% of patients in the overall population of patients with newly diagnosed stage IIIB-IV ovarian cancer remained progression-free.
Data from the phase 3 PAOLO-1 clinical trial showed that progression-free survival was significantly increased with olaparib plus bevacizumab as maintenance therapy.
The approval of 3 PARP inhibitors has made it feasible to personalize therapy for patients with ovarian cancer based on their mutation status as well as other factors, including the treatment setting.
The phase 3 PRIMA clinical trial demonstrated that time to first subsequent therapy was 6.6 months longer in the niraparib arm versus the placebo arm, an advantage that was maintained regardless of homologous recombination deficiency status, and the risk for second disease progression was also numerically lower in niraparib-treated patients.
On June 15, 2020, the FDA accelerated the approval of lurbinectedin (Zepzelca; Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. The FDA granted lurbinectedin an orphan drug designation for this indication.
On June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy. Nivolumab has been previously approved for many indications, but this is its first indication for esophageal cancer.
On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy.
Improvement in progression-free survival observed in the PRIMA clinical trial results in FDA approval of an additional indication for niraparib as first-line maintenance treatment of all patients with advanced ovarian cancer whose disease has had a complete or partial response to first-line platinum-based chemotherapy.
In this exclusive interview, Melissa Paige, Chief Executive Officer and Founder, Paige Consulting, LLC, Charlottesville, VA, and Infusion/Oncology Patient Access Principal Coordinator at a large academic center, shares her experience in helping patients with cancer obtain access to oral and infused therapies.
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