FDA Approves Combo Immunotherapy for Unresectable or Metastatic Melanoma

The Food and Drug Administration (FDA) approved Opdualag, a combination of the immunotherapy drugs relatlimab and Opdivo (nivolumab), for treating patients 12 years of age and older with unresectable or metastatic melanoma. In a clinical trial comparing Opdualag with Opdivo, the median time to cancer progression was 10.1 months for patients taking Opdualag compared with 4.6 months for Opdivo. The safety profile for the new therapy was similar to that of Opdivo. “Since the approval of the first immune checkpoint inhibitor more than 10 years ago, we’ve seen immunotherapy, alone and in combination, revolut​ionize the treatment of patients with advanced melanoma,” said medical oncologist Stephen Hodi, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute in Boston and a study co-author, in a media release. “Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints—LAG-3 and PD-1.”

New Screening Tool Improves Detection of Early-Stage Pancreatic Cancer

A novel screening platform identified more than 95% of stage I pancreatic cancers using a blood sample, according to results of a study published in Nature Communications Medicine. The new screening tool detects extracellular vesicles that contain tumor proteins released by cancer cells into the blood. The tool uses artificial intelligence to predict the likelihood of malignancy. Pancreatic cancer was the third-leading cause of U.S. cancer deaths in 2020, and early detection is key to effectively treating the disease. Currently only 5% of patients with pancreatic cancer are diagnosed at stage I, and only 10% are diagnosed in time for curative surgery. The screening result for pancreatic cancer is especially promising, said oncologist Scott M. Lippman, director of Moores Cancer Center in San Diego and co-senior author of the paper, in a media release​. “These results are five times more accurate in detecting early-stage cancer than current liquid biopsy multi-cancer detection tests.”

Treatment for Advanced Prostate Cancer Approved by FDA

The Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat some patients with castration-resistant metastatic prostate cancer. The FDA also approved a complementary diagnostic imaging agent to determine if the cancer expresses a certain biomarker that responds to treatment with Pluvicto. “Castration-resistant” refers to prostate cancer that has failed to respond to hormone therapies and chemotherapies intended to lower the levels of testosterone, which can help fuel prostate cancer. These patients have few additional treatment options once standard treatments have failed, and the five-year relative survival rate for people with metastatic prostate cancer is 30%. The FDA approval was based on results of a phase III clinical trial showing that patients treated with Pluvicto and standard of care had a 38% reduced risk of death compared with patients treated with standard of care alone. “The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC [metastatic castration-resis​​tant prostate cancer], as it can significantly improve survival rates for those who have limited treatment options,” oncologist Oliver Sartor, medical director at Tulane Cancer Center in New Orleans and a study co-author, said in a media release​. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”