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Backed by Dana-Farber research, FDA approves new drug combination for treating advanced kidney cancer

BOSTON - An immunotherapy drug combination whose clinical testing was co-led by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, has become a standard first-line therapy for patients with metastatic kidney cancer.

The drug combination of the immunotherapy drug avelumab (BAVENCIO) plus axitinib (INLYTA), a VEGF targeted agent, was approved today by the U.S. Food and Drug Administration (FDA) for patients with advanced clear cell renal cell carcinoma – the most common form of kidney cancer.

“I believe combination therapies offer an exciting new frontier in treating renal cell carcinoma, and I’m pleased the FDA has approved this new option,” said Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber.

The benefits of this drug combination were borne out in the JAVELIN Renal 101 trial. Choueiri is senior and co-corresponding author of the report which was published in The New England Journal of Medicine. Patients in the study receiving avelumab plus axitinib had a significant advantage in progression-free survival compared with those who received sunitinib (SUTENT). Read more on the JAVELIN trial here:

Choueiri said that for patients with advanced disease, “this is another option. What we’re doing in advanced kidney cancers is pushing the envelope – these treatments may not be curative, but patients are living longer, and the disease is becoming more chronic.”

The clinical trial is sponsored by Pfizer, Inc., and is part of an alliance between Pfizer and Merck KGaA.

Dr. Choueiri reports grants, research, grants, personal fees and non-financial support from Pfizer, during the conduct of the study.

Posted on May 15, 2019

  • Research
  • Toni Choueiri, MD
  • Immunotherapy
  • Kidney Cancer

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Toni K. Choueiri, MD