NEW YORK – Datar Cancer Genetics said this week that it has received breakthrough designation for its TriNetra-Prostate blood test for early-stage prostate cancer. The test detects prostate adenocarcinoma-specific circulating tumor cells and is indicated for men between the ages of 55 and 69 with serum PSA levels of 3 ng/ml or higher.
The US Food and Drug Administration this week granted orphan drug designation to a CAR T-cell therapy for advanced multiple myeloma that is jointly developed by Iaso Biotherapeutics and Innovent Biologics. The therapy, which received breakthrough therapy designation from China's National Medical Products Administration in early 2021, is designed to target the B-cell maturation antigen on multiple myeloma cells. The firms are developing the CAR T-cell therapy as a frontline treatment for relapsed or refractory multiple myeloma as well as in combination with other treatments, both in China and the US.
Roche subsidiary Foundation Medicine said this week that its FoundationOne Tracker test for circulating tumor DNA detection and molecular monitoring has received breakthrough device designation from the US Food and Drug Administration. The test uses optimized algorithms to identify patient-specific variants and a personalized assay design to detect ctDNA in plasma, the company said in a statement. The breakthrough device designation was granted for the assay’s use in the detection of molecular residual disease in early-stage cancer after curative therapy. The test, an RUO version of which launched in June 2021, can help guide further therapy decisions depending on MRD status and the risk of relapse. It was developed in collaboration with Natera and combines Foundation’s tissue-based comprehensive genomic profiling platform with Natera’s expertise in personalized ctDNA monitoring.
The US Food and Drug Administration this week accepted the new drug application (NDA) for Mirati Therapeutics' adagrasib for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer who have received at least one systemic therapy. The NDA is based on data from the Phase II KRYSTAL-1 study. Last September, the company reported that the objective response rate on adagrasib was 43 percent and the disease control rate was 80 percent among the advanced KRAS G12C-mutant NSCLC cohort. Adagrasib is being reviewed under the accelerated approval pathway, and the FDA's decision is expected by Dec. 14. Mirati has already begun a Phase III confirmatory trial, KRYSTAL-12, comparing adagrasib to docetaxel in patients with second-line KRAS G12C-mutated NSCLC.
The US Food and Drug Administration this week accepted Bristol Myers Squibb's supplemental biologics license application for its CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) for second-line treatment for relapsed or refractory large B-cell lymphoma. The application is based on data from the Phase III TRANSFORM trial, in which Breyanzi improved patients' event-free survival versus standard-of-care chemotherapy and stem-cell transplant. The FDA expects to make a decision on whether to expand the indication for Breyanzi — which is already approved as a later-line treatment for lymphoma — into the earlier treatment setting by June 24 of this year.
Zai Lab this week said repotrectinib was granted breakthrough therapy designation by the Center for Drug Evaluation within China's National Medical Products Administration for the treatment of tyrosine kinase inhibitor-naive patients with ROS1-positive metastatic non-small cell lung cancer. The designation was based on data from the Phase I/II TRIDENT-1 study. Zai Lab licensed repotrectinib from Turning Point Therapeutics in June 2020 for development and commercialization in greater China. Last year, repotrectinib was granted fast-track designation by the US Food and Drug Administration for the same patient population.
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.