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A Biomarker For Bristol: Mutation Burden Shows Promise In Small Cell Lung Cancer

 
• By Emily Hayes

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

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Bristol-Myers Squibb Co.'s latest data for the combination of Opdivo and Yervoy suggest a role for the duo in a new indication for small cell lung cancer (SCLC) and generally give more support to the emerging biomarker of "tumor mutation burden" in guiding immunotherapy treatment.

PD-L1 expression has been the most commonly used biomarker for checkpoint inhibitor immunotherapies to date, but is a flawed measure in that it does not always correlate with response

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More from Approval Standards

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

More from Pathways & Standards

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.