NEW YORK – The US Food and Drug Administration has accepted for priority review a new drug application from Taiho Oncology for its FGFR1/2/3/4 inhibitor futibatinib for the treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 rearrangements, including gene fusions. The company said this week that the FDA is slated to make a decision on the application by Sept. 30.
Dutch diagnostics firm PamGene said this week that it has received renewal and an amended scope for its ISO 13485:2016 certification from Dekra Certification. The standard certifies the quality of the company's design, development, and manufacturing of in vitro diagnostic devices for the prediction of therapy response for cancer, PamGene said, adding that the expansion of the certification is an "important milestone" for the launch of its IOpener liquid biopsy immunotherapy response test. The company is preparing to launch IOpener test services in Europe and will use Dekra as its notified body under Europe's forthcoming In Vitro Diagnostic Regulation requirements.
Mursla this week announced a prospective pilot study to identify novel biomarkers that can detect early-stage liver cancer. The study, supported by Roche Diagnostics, will enable the development of a liquid biopsy assay. Mursla will analyze hundreds of blood samples using its multiomic exosome characterization platform ExoPheno and identify exosome subpopulations for patients with chronic liver disease and cancer at various stages. The study and collaboration with Roche were started through Collaborate to Innovate: London Diagnostics, a program run by London-based life sciences nonprofit MedCity.
The European Medicines Agency this week granted orphan medical product designation to Autolus Therapeutics' CAR T-cell therapy obecabtagene autoleucel for the treatment of acute lymphoblastic leukemia. Autolus is currently studying obe-cel, an autologous CD19-directed therapy, in the Phase Ib/II FELIX trial in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The EMA grants orphan designation to medical products for serious, rare diseases. Companies have reduced fees for regulatory activities related to orphan-designated products and 10 years of market exclusivity in the EU following EMA approval.
Clovis Oncology said this week that based on recently released data, it will seek approval for its PARP inhibitor Rubraca (rucaparib) as a first-line maintenance treatment for patients with platinum-responsive advanced ovarian cancer, regardless of their biomarker status. In the 538-patient ATHENA-MONO trial, newly diagnosed women with advanced, high-grade ovarian, fallopian tube, or primary peritoneal cancer who received first-line maintenance treatment with Rubraca after responding to platinum-based chemotherapy, had a median progression-free survival of 20.2 months compared to 9.2 months on placebo. In patients with homologous recombination repair deficiencies, such as BRCA1/2 mutations, median progression-free survival was 28.7 months with Rubraca compared to 11.3 months on placebo.
Clovis plans to submit a supplemental new drug application with the US Food and Drug Administration in Q2 seeking approval for Rubraca as a first-line maintenance treatment for advanced ovarian cancer patients after platinum-based chemo, regardless of biomarker status. The Boulder, Colorado-based firm will also file a type II variation application with the European Medicines Agency in Q3, seeking approval for the same indication. Rubraca is already approved in the US as a maintenance treatment for patients with recurrent ovarian cancer after platinum chemo and for patients with BRCA1/2 mutations after two lines of chemo.
Oncolytics Biotech said this week that a review by a data safety monitoring board found no safety concerns in a three-patient safety run-in for its Phase I/II GOBLET trial. In this study, the company will assess safety and efficacy of its pelareorep agent in combination with Roche's PD-L1 checkpoint inhibitor Tecentriq (atezolizumab) in patients with metastatic pancreatic cancer, metastatic colorectal cancer, and advanced anal cancer. Pelareorep is an isolate of human reovirus designed to induce apoptosis in RAS-activated tumor cells. The trial will assess objective response rate and safety as primary endpoints and potential biomarkers (T-cell clonality and CEACAM6) as secondary endpoints.
Castle Biosciences said this week that the Centers for Medicare & Medicaid Services has granted its TissueCypher Barrett's Esophagus test Advanced Diagnostic Laboratory Test (ADLT) status, effective March 24. TissueCypher is a prognostic assay designed to predict development of high-grade dysplasia or esophageal cancer in patients with Barrett's esophagus.
ADLT status requires that a test provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests, among other criteria. TissueCypher is Castle's fourth test to receive this status, joining DecisionDx-UM, DecisionDx-Melanoma, and MyPath Melanoma.
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.