Feature

FDA scrutinizes cancer therapies granted accelerated approval


 

Four cancer indications recently withdrawn voluntarily by the manufacturer

  • December 2020: Nivolumab for the treatment of patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy (Bristol Myers Squibb).
  • February 2021: Durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (AstraZeneca).
  • March 2021: Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy (Merck).
  • March 2021: Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing atezolizumab chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Genentech).

Six cancer indications under review at the April 2021 ODAC meeting

  • Atezolizumab indicated in combination with protein-bound for the treatment of adults with unresectable locally advanced or metastatic triple-negative whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.
  • Atezolizumab indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
  • Pembrolizumab indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
  • Pembrolizumab indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score ≥1), as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
  • Pembrolizumab indicated for the treatment of patients with who have been previously treated with .
  • Nivolumab indicated as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

A version of this article first appeared on Medscape.com.

Pages

Recommended Reading

CXR-Net: An AI-based diagnostic tool for COVID-19
MDedge Hematology and Oncology
New approach to breast screening based on breast density at 40
MDedge Hematology and Oncology
How has the pandemic affected rural and urban cancer patients?
MDedge Hematology and Oncology
New ASH guidelines: VTE prevention and treatment in cancer patients
MDedge Hematology and Oncology
JAMA podcast on racism in medicine faces backlash
MDedge Hematology and Oncology
Genetic testing for breast and ovarian cancer: What has changed and what still needs to change?
MDedge Hematology and Oncology
JAMA editor resigns over controversial podcast
MDedge Hematology and Oncology
mCODE: Improving data sharing to enhance cancer care
MDedge Hematology and Oncology
Don’t delay: Cancer patients need both doses of COVID vaccine
MDedge Hematology and Oncology
SNP chips deemed ‘extremely unreliable’ for identifying rare variants
MDedge Hematology and Oncology