Among patients with oncogene-driven advanced non–small cell lung cancer (NSCLC) who were treated with tyrosine kinase inhibitors (TKIs), improved survival end points were associated with circulating tumor DNA (ctDNA) clearance within 10 weeks of treatment initiation, according to findings published in AACR Journals. This means that patients undergoing TKI treatment for their lung cancer, which is…
It was great news for clinical labs when a federal district court decided on March 31 to vacate the Food and Drug Administration’s (FDA’s) final rule that would have given the agency power to regulate laboratory developed tests (LDTs). The rule would have greatly increased regulatory requirements for labs offering LDTs. The decision in the…
Biodesix, Inc (Nasdaq: BDSX), a leading diagnostics solutions company, and Bio-Rad Laboratories (NYSE: BIO), a global leader in life science research and diagnostics products, contributed to new research findings from Friends of Cancer Research’s (Friends’) ctMoniTR Project, recently published in Clinical Cancer Research (CCR). The findings demonstrate a strong association between changes in levels of circulating tumor DNA (ctDNA)…
Industry comments on two recent US Food and Drug Administration guidance documents on accelerated approval seek clear timelines for agency feedback on confirmatory study protocols and a better understanding of how the FDA defines “due diligence” for purposes of timely study conduct. Industry stakeholders also seek assurances that the FDA will be flexible in deciding…
FDA Commissioner Marty Makary has announced his intention to create a new pathway for drugs that treat ultrarare conditions. “We’re going to be rolling out a new pathway for drugs, which is a pathway based on a plausible mechanism,” Makary said in an interview Thursday with The Megyn Kelly Show. “If there’s a rare condition or a…
Most patients who enroll in the Lung-MAP precision medicine trial in non-small cell lung cancer can now be matched to a targeted investigational treatment based on the results of their prior genomic testing, without needing to submit new tumor or blood samples. This expanded screening process will help make Lung-MAP’s targeted treatment studies more accessible…
Friends of Cancer Research launched the AI-Based Measurement of Response Evaluation Criteria in Solid Tumors, or ai.RECIST, research partnership April 15, 2025. The effort brings together 27 entities across biopharma, tech and academia, though the FDA and other government agencies are conspicuously absent. The first priority: assessing tool capabilities using lung cancer trial data. Background:…
A proposal for reorganizing the US Food and Drug Administration into five offices and consolidating all product review functions is “a mindless approach to centralization and standardization” and would not adequately support the agency’s functions, former agency officials said. The proposal for a reorganized FDA that is being circulated by the Trump Administration “is a…
More than 200 biotech leaders have penned a letter voicing concerns over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards. Certain biotechs have already seen the effects of the FDA restructure, according to the authors, who urge the government to “quickly preserve and…
During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a “slow-moving catastrophe.” Dr. Woodcock was referring to drug development, but the same could be said for medical device development. Devices will still move…
