ICYMI: May 20 Updates on Recent FDA Approvals

Wednesday, May 20, 2020

The FDA continues to approve new cancer drugs, with multiple treatment regimens getting the agency’s OK within the last week. In case you missed it, here is a list of the 5 most recent FDA approvals in the cancer space:
  • Olaparib for HRRmutant metastatic, castration-resistant prostate cancer. The PARP inhibitor, Olaparib (Lynparza) was approved for patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) genemutant, metastatic, castration-resistant prostate cancer (mCRPC) that progressed after treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).
  • Atezolizumab for PDL1—high non-small cell lung cancer. Atezolizumab (Tecentriq) was approved for adults with nonsmall cell lung cancer (NSCLC) who have a high PD-L1 expression (50% or higher) and no EGFR or ALK mutations.
  • Ripretinib for advanced gastrointestinal stromal tumors. The approval for ripretinib (Qinlock) is for patients with advanced gastrointestinal stromal tumors who had at least 3 prior therapies with kinase inhibitor therapies. In the study leading up to the drug’s approval, ripertinib shoed an 85% reduction in the risk of disease progression or death.
  • Nivolumab plus ipilimumab for metastatic NSCLC. The immunotherapy combo of nivolumab (Opdivo) plus ipilimumab (Yervoy) was approved for the frontline treatment of patients with metastatic or recurrent NSCLC that has no EGFR or ALK mutations. The trial leading up to the approval showed that the 2drug regimen had better overall survival rates compared to nivolumab alone or chemotherapy.
  • Rucaparib for BRCAmutant mCRPC. Rucaparib (Rubraca), a PARP inhibitor was approved for patients with BRCA1/2mutant mCRPC. Adverse events for nurses to look out for include: asthenia/fatigue, nausea, anemia, ALT/AST increased, decreased appetite, constipation, rash, thrombocytopenia, vomiting, and diarrhea.

More FDA decisions are coming down the pipeline as well. While they recently have been approving agents ahead of schedule, here is a list of upcoming PDUFA decision dates to keep an eye out for:
  • June 16: Pembrolizumab (Keytruda) for tumor mutation burdenhigh tumors
  • June 18: Tazemetostat (Tazverik) for relapsed/refractory follicular lymphoma
  • June 23: Selinexor (Xpovio) for relapsed/refractory diffuse large Bcell lymphoma
  • June 30: Sb8, a biosimilar for bevacizumab

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