NEW YORK – The US Food and Drug Administration this week granted breakthrough therapy designation to AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan (Enhertu) as a treatment for unresectable or metastatic HER2-positive breast cancer patients after at least one other anti-HER2 regimen. The agency deemed the antibody-drug conjugate a breakthrough therapy based on data from the DESTINY-Breast03 Phase III trial, which showed that the drug reduced the risk of disease progression or death by 72 percent compared to ado-trastuzumab emtansine (Genentech’s Kadcyla; T-DM1). Trastuzumab deruxtecan is already approved in the US, Japan, the EU, and elsewhere for treating unresectable or metastatic HER2-positive breast cancer patients who have received at least two other anti-HER2 regimens for metastatic disease.
Turning Point Therapeutics said this week that the US Food and Drug Administration has granted breakthrough therapy designation to the firm's investigational agent repotrectinib for patients with advanced solid tumors harboring NTRK gene fusions. The agency granted the designation to repotrectinib specifically for patients who have experienced disease progression after one or two prior TRK-targeting drugs. Turning Point said it will discuss regulatory plans for repotrectinib during an upcoming meeting with the FDA sometime in the first half of 2022.
Recursion said this week that the FDA has granted fast-track designation to its investigational HDAC inhibitor therapy REC-2282 for NF2-mutated meningioma patients, including those with meningiomas driven by neurofibromatosis type-2 disease. The designation comes as the Salt Lake City-based firm advances the agent toward a Phase II/III randomized trial slated to begin in early 2022.
Cleveland Clinic and Brooks Automation's life sciences division Azenta Life Sciences this week opened a biospecimen sample management and repository facility on Cleveland Clinic's main campus. The facility will increase the hospital's biobanking capacity and accelerate the health center's translational research in precision medicine for cancer, heart disease, epilepsy, and other diseases. The facility will be managed by Azenta and will make samples available to researchers at Cleveland Clinic and other institutions.
Florida Cancer Specialists & Research Institute this week said it has expanded its molecular testing capabilities within its pathology laboratory in Fort Myers and now will offer at its clinics throughout the state a broad suite of next-generation sequencing tests to patients with solid tumors and hematologic malignancies. FCS has independently validated a 500-plus gene solid tumor panel from Illumina for use in its laboratory, and also has access to Invitae's VariantPlex Myeloid panel and FusionPlex PanHeme panel performed on the Illumina NextSeq 550Dx sequencing platform. The results from these tests will be interpreted by FCS's variant scientists using PierianDx CGW software. These capabilities will improve precision oncology therapy access for patients seen in the community setting, according to FCS, and identify clinical trial opportunities.
Bioinformatics firm Deep Lens and hematology-oncology practice Pacific Cancer Care have formed a partnership to improve clinical trial matching and enrollment. Pacific Cancer Care will apply Deep Lens' VIPER platform to identify patients who might be eligible for clinical trials, bring more trials to its practice, and improve communications between patient care teams. VIPER, which stands for Virtual Imaging for Pathology Education and Research, combines artificial intelligence with advanced pathology workflows to enable peer-to-peer collaboration and patient identification for clinical trials. The technology harmonizes and normalizes genetic test results, enabling Deep Lens to deliver a simplified, standardized picture of what is happening to any given patient at the molecular level and providing physicians with knowledge about specific mutations that may qualify patients for specific clinical trials.
VIPER will help Pacific Cancer Care prescreen patients from the practice's OncoEMR electronic medical records system and integrate data feeds from molecular laboratories including Caris Life Sciences, Foundation Medicine, and Guardant Health, then analyze the data to flag patients who qualify for active clinical trials.
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.