Oncology

Keytruda, Tecentriq Labeling Updated With PD-L1 Testing Requirements

By August 17, 2018

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.

CPI-613 Gets Orphan Drug Designation for Peripheral T-Cell Lymphoma

By August 17, 2018

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.

Lenvima OK'd as First-Line Treatment for Unresectable Hepatocellular Carcinoma

By August 16, 2018

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.

Talazoparib Beneficial in Patients With Advanced Breast Cancer

August 16, 2018

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).

Elzonris Granted Priority Review for Blastic Plasmacytoid Dendritic Cell Neoplasm

By August 14, 2018

The Company announced results from a Phase 2 trial involving 45 patients with BPDCN earlier this year.

Jury Awards &#36;289 Million in Case Linking Roundup to Man's Cancer

August 14, 2018

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.

Enzalutamide reduces risk of metastatic prostate cancer in at-risk men

August 13, 2018

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.

Fruquintinib increases overall survival in metastatic colorectal carcinoma

August 10, 2018

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.

Vicinium Fast-Tracked for Non-Muscle Invasive Bladder Cancer

By August 10, 2018

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.

Supplemental BLA Submitted for Darzalex Split Dosing Regimen

By August 09, 2018

The proposed dosing regimen would provide the option of splitting the first infusion of Darzalex over 2 consecutive days.

Poteligeo Approved for 2 Rare Types of Non-Hodgkin Lymphoma

By August 08, 2018

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).

Triple Therapy Gets Breakthrough Designation for <i>BRAF</i>-Mutant mCRC

By August 08, 2018

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.

Biomarker Panel May Improve Lung Cancer Risk Assessment

August 06, 2018

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.

Skin Appears to Be Key Pathway for Absorption of BBQ Fumes

August 06, 2018

"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.

FDA: Cancer Relapse Linked to Azithromycin Use to Prevent Serious Lung Condition

By August 03, 2018

Pfizer has terminated the ALLOZITHRO trial (N=480) due to this increased risk.

Lurbinectedin Gains Orphan Drug Status for Small Cell Lung Cancer

By August 03, 2018

A Phase 2 multicenter trial examined the safety and efficacy of lurbinectedin in several types of advanced solid tumors, including SCLC.

NIH Releases Large-Scale Dataset of CT Images

August 03, 2018

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.

<i>TGFB1</i> Mutation Ups Radiation-Induced Breast Fibrosis Risk

August 02, 2018

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.

Treatment for FLT3-ITD Acute Myeloid Leukemia Gets Breakthrough Designation

By August 02, 2018

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).

Anti-CD47 Antibody Granted Orphan Drug Designation for Multiple Myeloma

By August 01, 2018

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 Approved to Treat Rare Tumors of the Adrenal Gland

By July 31, 2018

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.

Could Zika Virus Be a Potential Treatment for Neuroblastoma?

By July 26, 2018

Even with intensive therapy, survival among neuroblastoma patients is poor, indicating a need for alternative treatments.

FDA Approves Magnetic System for Guiding Lymph Node Biopsies

July 26, 2018

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.

HPV Vaccine Eliminates Advanced Skin Cancer in 97-Year-Old

July 24, 2018

Doctors tried an unorthodox approach - injecting each tumor with Gardasil, the HPV vaccine. The result: All the tumors completely and rapidly disappeared.

Can Monthly Vitamin D Supplementation Cut Cancer Risk?

July 24, 2018

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.

FDA: Cancer Treatment 'Alternative' May Cause Serious Heart Problems, Death

By July 23, 2018

Cesium chloride is not approved by the FDA to treat cancer or any other disease.

Tibsovo Approved for Relapsed/Refractory AML With IDH1 Mutation

By July 20, 2018

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.

Galinpepimut-S Fast-Tracked for Multiple Myeloma Treatment

By July 20, 2018

As WT1 is present in an array of tumor types, the Company believes GPS has the potential to be a broad immunotherapy.

Link for Asbestos-Free Talcum Powder, Cancer Not Clear

July 19, 2018

Perineal use of talc-based body powder is classified as "possibly carcinogenic to humans."

Researchers Develop First Blood Test for Melanoma

July 19, 2018

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.