NEW YORK – The Access to Comprehensive Genomic Profiling Coalition (ACGP) said this week that it has added Blueprint Medicines to its coalition of companies advocating for payors to cover comprehensive genomic profiling (CGP) for advanced cancer patients. As part of its advocacy efforts, the coalition educates health insurers and other stakeholders across healthcare about CGP's clinical utility and economic value. ACGP considers any company that either offers CGP tests or offers products with CGP as eligible for potential coalition membership. Current members also include Labcorp, Exact Sciences, Invitae, Roche, Thermo Fisher Scientific, Strata Oncology, Tempus, Illumina, Foundation Medicine, NeoGenomics, and PGDx.
The US Food and Drug Administration this week accepted a supplemental biologics license application for Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan-nxki) for previously treated metastatic non-small cell lung cancer patients whose tumors harbor HER2 mutations. The agency also granted the application priority review status based on the encouraging results from the DESTINY-Lung01 clinical trial. The FDA is expected to make a decision on the drug's approval in this indication during the third quarter of this year.
Gilead Sciences subsidiary Kite said this week that the FDA has approved commercial production at the firm's new CAR T-cell therapy manufacturing facility. Kite will use the 275,000-square-foot facility located in Frederick, Maryland, to produce its FDA-approved CAR T-cell therapies, including Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). The drugmaker estimates that its expanded manufacturing network will allow for a 50 percent increase in capacity, better positioning Kite to meet patient demand for the CAR T-cell therapy.
Zai Lab this week engaged accounting firm KPMG to audit its annual consolidated financial statements filed with the US Securities and Exchange Commission and the Hong Kong Stock Exchange. Last month, the SEC identified that Zai Lab did not use an auditor that was subject to Public Company Accounting Oversight Board (PCAOB) inspection. If a company does not use an auditor subject to the PCAOB for three consecutive years, the SEC could delist its stock on the Nasdaq under the Holding Foreign Companies Accountable Act.
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.