The Dako PD-L1 IHC 22C3 PharmDx Assay has been approved as a companion diagnostic to identify patients with with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda.
This first-in-class drug was previously granted Orphan Drug designation for the treatment of pancreatic cancer, acute myeloid leukemia, Burkitt lymphoma, and myelodysplastic syndromes.
The approval was supported by findings from the multicenter, randomized, open-label, noninferiority trial, REFLECT (N=945), which included patients with previously untreated, metastatic or unresectable HCC.
The talazoparib group had a higher objective response rate than the standard-therapy group (62.6 vs 27.2%; odds ratio, 5.0; 95% confidence interval, 2.9 to 8.8; P<.001).
The Company announced results from a Phase 2 trial involving 45 patients with BPDCN earlier this year.
Glyphosate -- the active ingredient in Roundup -- is safe when used according to label directions, according to the US Environmental Protection Agency. But in 2015, glyphosate was classified as a "probable human carcinogen," by the International Agency for Research on Cancer.
Prostate cancer patients with a rapidly risking prostate-specific antigen (PSA) despite chemical or physical castration had lower rates of metastasis when treated with enzalutamide compared to those in a placebo group.
In this phase 3 randomized controlled trial, fruquintinib increased median overall survival and progression-free survival compared to placebo in patients with colorectal cancer who had already undergone second line or subsequent treatment.
A Phase 3 trial (Vista) of the treatment is currently taking place; the trial is evaluating the treatment in patients with NMIBC who have previously received 2 courses of BCG and who are now BCG-unresponsive.
The FDA approval was supported by data from MAVORIC, a phase 3, randomized, open-label, multicenter trial (N=372) of patients with relapsed MF or SS who received Poteligeo or vorinostat (Zolinza; Merck).
The Company announced early data from their Phase 3 trial ('Beacon CRC') of encorafenib, binimetinib and cetuximab in 29 patients with BRAF V600E-mutant mCRC which showed that the triple therapy had good tolerability.
The integrated risk prediction model combining smoking exposure with the biomarker score yielded an area under the curve of 0.83 versus 0.73 for a model based on smoking exposure alone.
"In the case of BBQ fumes, dermal absorption was a more important pathway for intake of low-molecular-weight PAHs than inhalation," the authors write.
A Phase 2 multicenter trial examined the safety and efficacy of lurbinectedin in several types of advanced solid tumors, including SCLC.
Unlike most lesion medical image datasets currently available, which can detect only 1 type of lesion, DeepLesion has much diversity and contains critical radiology findings from across the body, including lung nodules, liver tumors, and enlarged lymph nodes.
The researchers found that 13.8% of patients with C-509T and 3.8% of those without the allele variant had grade 2 or higher breast fibrosis.
The designation was based on results from the Phase 3 QuANTUM-R trial, which included 367 participants who were randomized to receive quizartinib or salvage chemotherapy (SC).
SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis.
Azedra should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals.
In clinical testing, about 98% of patients had the same detection rate with the Sentimag System vs the control method of injecting patients with radioactive dye.
Doctors tried an unorthodox approach - injecting each tumor with Gardasil, the HPV vaccine. The result: All the tumors completely and rapidly disappeared.
The primary outcome of cancer (328 total cases of cancer) occurred in 6.5 and 6.4% of participants in the vitamin D and placebo groups, respectively.
The approval of Tibsovo was based on an open-label, single-arm, multicenter clinical trial (Study AG120-C-001) involving 174 patients with relapsed or refractory AML with an IDH1 miutation.
The researchers identified a combination of 10 autoantibody biomarkers that, as a panel, displayed a sensitivity, specificity, and an area under the curve of 79%, 84%, and 0.828, respectively, for primary melanoma detection.