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In Brief This Week: FDA, Inivata, Allegheny Health Network Cancer Institute, NEC Corporation

NEW YORK – The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) said this week that it will hold a public meeting from April 27 to April 29 to review the status of several immunotherapy indications to which it previously granted accelerated approval. Among the indications to be reviewed by the ODAC are atezolizumab (Genentech's Tecentriq) with paclitaxel protein-bound for PD-L1-positive, advanced, or metastatic triple-negative breast cancer; and pembrolizumab (Merck's Keytruda) for PD-L1-positive, advanced, or metastatic gastric or gastroesophageal junction cancer after progression on two lines of fluoropyrimidine- and platinum-containing chemotherapy.  

When the FDA approves drugs at an accelerated clip, the sponsor is required to submit additional data on the treatment's safety and efficacy in the post-market setting to maintain approval. The agency said that its Oncology Center of Excellence requested the latest review by the ODAC as part of an "industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical benefit." At the meeting, the drugmakers will have an opportunity to provide updates, and the committee members will discuss whether to allow the drugs to remain available for these indications and if further trials are necessary.

The agency's ongoing evaluation of treatments with accelerated approval has already resulted in pharma companies voluntarily withdrawing several indications for checkpoint inhibitors from the market. Last week, Roche said it would no longer market atezolizumab as an option for advanced bladder cancer patients who have progressed on platinum-containing therapy, after the IMvigor211 study failed to show an overall survival improvement in the PD-L1-high patient population. According to the FDA, 6 percent of accelerated approvals for oncology indications have been withdrawn since the inception of the rapid review program. 


Inivata said this week that the US Food and Drug Administration has granted breakthrough device designation to its RaDaR liquid biopsy assay. The next-generation sequencing assay tracks up to 48 tumor-specific variants to detect residual disease following initial cancer treatment.  


Allegheny Health Network Cancer Institute opened a clinical genomics laboratory this week that offers next-generation sequencing to patients with metastatic and some early-stage tumors, including breast, colon, and lung cancer. The NGS panel interrogates 523 genes, including structural rearrangements and tumor mutation burden. The lab is also developing a blood-based assay to monitor treatment response and disease recurrence. The latest offering is part of a precision oncology partnership between Allegheny Health Network and health insurer Highmark Health that also includes a translational research lab and genomics repository.


NEC Corporation this week said it has joined the Norwegian Precision Cancer Medicine Implementation Consortium (CONNECT), a public-private collaboration between 22 partners with the goal of advancing precision cancer medicine. CONNECT fosters collaboration in diagnostics and clinical trials, on implementation of advanced precision medicine, and on the use of health data, including for health economics analysis. In joining the consortium, NEC — which has developed an artificial intelligence-based neoantigen prediction system — hopes to tap into real-world data to accelerate its immunotherapy activities.  


Caris Life Sciences said this week that Curie Oncology is the newest member of its Precision Oncology Alliance, within which cancer centers work on advancing comprehensive cancer profiling and establishing molecular testing standards through research on predictive and prognostic markers. The alliance now includes 49 cancer centers and academic institutions that have early access to Caris' database and artificial intelligence platform, as well as to the Caris CODEai data solution, which contains cancer treatment information and clinical outcomes data on more than 244,000 patients. Curie Oncology is a boutique oncology practice in Singapore that provides multidisciplinary cancer care and specializes in using diagnostics to inform treatment strategies for complex cases.


PathAI and Laboratory Corporation of America announced they have broadened an existing partnership that will allow PathAI's algorithms to be deployed within programs for cancer and other diseases managed by LabCorp Drug Development. According to PathAI, its algorithms can be used to develop and commercialize companion diagnostics, to quantify tissue-based biomarkers, and select and stratify patients in retrospective and prospective trials. The partners will also evaluate the use of AI-powered algorithms in a clinical laboratory setting. Financial and other terms were not disclosed. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.