FDA Label Change Takes a Bite Out of Prescriptions

Jason Harris
Published: Tuesday, Nov 26, 2019
Ravi B. Parikh, MD, MP, an instructor in Medical Ethics and Health Policy at the University of Pennsylvania in Philadelphia

Ravi B. Parikh, MD, MP

Immunotherapy prescriptions for patients with metastatic bladder cancer declined rapidly after the FDA altered the indications of 2 drugs, suggesting that practicing oncologists can keep pace with changes associated with the agency’s accelerated approval program. Data published in JAMA showed that usage rates for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) in this population dropped by approximately 40% within 8 months of a label change.1,2

“Until the requirements to transition from accelerated approval to regular approval are met, the clinical community will have less information about the risks and benefits of drugs approved by the accelerated approval program,” wrote Bishal Gyawali, MD, PhD, and colleagues. “Appropriate use of this pathway will require that confirmatory trials are conducted in a timely fashion, using clinically meaningful or validated end points.”


  1. Parikh RB, Adamson BJS, Khozin S, et al. Association between FDA label restriction and immunotherapy and chemotherapy use in bladder cancer. JAMA. 2019;322(12):1209-1211. doi: 10.1001/ jama.2019.10650
  2. Oncologists respond swiftly to FDA safety alerts, Penn study finds [news release]. Philadelphia, PA; Penn Medicine; September 24, 2019. bit.ly/2OaLfuK. Accessed September 30, 2019.
  3. O’Connor JM, Fessele KL, Steiner J, et al. Speed of adoption of immune checkpoint inhibitors of programmed cell death 1 protein and comparison of patient ages in clinical practice vs pivotal clinical trials. JAMA Oncol. 2018;4(8):e180798. doi: 10.1001/ jamaoncol.2018.0798.
  4. FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1 [news release]. Silver Spring, MD: FDA; August 16, 2018. bit.ly/2yJSWiV. Accessed September 30, 2019.
  5. Gyawali B, Hey SP, Kesselheim AS. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med. 2019;179(7):906-913. doi: 10.1001/jamainternmed.2019.0462.

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