Oncology

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.

FDA Approves Additional Breast Cancer Indications for Kisqali

By July 18, 2018

In addition, Kisqali has also been approved in combination with fulvestrant to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

Ready-to-Administer Gemcitabine Formulation Gets FDA Approval

By July 18, 2018

Infugem utilizes a novel technology that enables cytotoxic oncology products to be premixed in a sterile setting and to be supplied to prescribers in RTA infusion bags.

Antibody-Drug Conjugate Gets Priority Review for Metastatic Triple-Negative Breast Cancer

By July 18, 2018

The FDA has set a Prescription Drug User Fee Act date of January 18, 2019 for the treatment.

Higher Risk of In-Situ Breast CA, Ovarian Tumors With Fertility Tx

July 17, 2018

Researchers examined the risks of ovarian, breast, and corpus uteri cancer in 255,786 women who underwent assisted reproduction, with 2,257,789 person-years of follow-up.

FDA Approves Expanded Prostate Cancer Indication for Xtandi

By July 16, 2018

The approval was based on data from the Phase 3 PROSPER trial which enrolled 1401 patients with non-metastatic CRPC.

Higher Vitamin D Levels May Lower Breast Cancer Risk

July 13, 2018

When adjusting for age, body mass index, smoking status, calcium supplement intake, and study of origin, women with 25(OH)D concentrations ≥60ng/mL had an 80% lower risk of breast cancer than women with concentrations <20ng/mL (hazard ratio, 0.20; P=.03).

Opdivo + Yervoy Approved to Treat MSI-H/dMMR Metastatic Colorectal Cancer

By July 12, 2018

The approval was based on data from the ongoing Phase 2 CheckMate-142 study which enrolled patients with MSI-H/dMMR metastatic CRC who had received ≥1 prior line of therapy for metastatic disease (N=119).

Keytruda sBLA Granted Priority Review for Advanced Hepatocellular Carcinoma

By July 11, 2018

The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment.

Physician Sued by Noncompliant Patient After Failing to Follow Up on Test

By July 10, 2018

Timely review and appropriate follow up on all patient reports is essential and must be part of a practice's routine.

Patient Interest Fairly High for Melanoma Genetic Risk Testing

July 10, 2018

The researchers found that 232 of the 499 participants randomized to MC1R testing logged on to the website, and of these, 88% (204 participants) requested testing and 82% (167 participants) returned the test kit.

Mammography Use Tied to Other Preventive Tests in Older Women

July 09, 2018

The researchers found that women who underwent index screening mammography were more likely than unscreened women to later undergo Papanicolaou test (odds ratio, 1.49), bone mass measurement (odds ratio, 1.70), and influenza vaccine (odds ratio, 1.45).

Cabozantinib Improves Survival in Advanced Hepatocellular Cancer

July 06, 2018

Significantly longer overall and progression-free survival with cabozantinib than placebo

Keytruda, Tecentriq Labeling Updated to Limit Use in Urothelial Cancer

By July 05, 2018

The updates come after the Agency made the decision to limit the use of these agents as monotherapy in patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

Pembrolizumab Not Better Than Paclitaxel for Advanced Gastric Cancer

July 03, 2018

Survival no better with second-line pembrolizumab than paclitaxel for gastric, gastro-esophageal cancer

Glasdegib NDA Granted Priority Review for Acute Myeloid Leukemia

By June 28, 2018

Glasdegib, an investigational oral smoothened (SMO) inhibitor, is a once-daily therapy that is thought to work by disrupting the Hedgehog pathway.

Enzalutamide Improves Outcomes for Aggressive Prostate Cancer

June 28, 2018

The researchers found that a total of 219 of 933 patients (23%) in the enzalutamide group had metastasis or had died vs 228 of 468 (49%) in the placebo group.

New Guidelines Increase Melanoma Staging Reproducibility

June 28, 2018

The researchers found that for T1a diagnoses, participating pathologists' concordance with the consensus reference diagnosis increased from 44% with AJCC 7 criteria to 54% with AJCC 8 criteria.

FDA Approves Combination Therapy for Advanced BRAF-Mutant Melanoma

By June 27, 2018

The approval of these kinase inhibitors was supported by data from the Phase 3, randomized, active-controlled, open-label, multicenter COLUMBUS trial (N=577).

Higher Rates of Cancers Observed Among Flight Attendants

June 27, 2018

Especially breast cancer, melanoma, and non-melanoma skin cancer among female flight attendants

Authors Explore Overdiagnosis in Cancer Screening

June 27, 2018

Current data suggest that people remain highly interested in being screened despite recognizing that a detected cancer may be indolent, which is partly due to fear of cancer.

Modified Polio Vaccine Looks Promising in Early Glioblastoma Trial

By June 26, 2018

PVSRIPO is a prototypic oncolytic recombinant polio virus vaccine that recognizes the poliovirus receptor CD155, which is widely expressed in neoplastic cells of solid tumors.

Study Compares Treatment Options for T1a Renal Cancer

June 26, 2018

The researchers found that the 5-year RCC-specific survival rate was 95 vs 98% after PA vs PN and 96 vs 95% after PA vs RN. The 5-year overall survival rate was 77 vs 86% after PA vs PN and 74 vs 75% after PA vs RN.

Combination Therapy for Waldenström's Macroglobulinemia Gets Priority Review

By June 26, 2018

The sNDA is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial which assessed ibrutinib in combination with rituximab vs rituximab alone in 150 patients with previously untreated and relapsed/refractory WM.

Aspirin Use Doesn't Cut Cancer Incidence in Older T2DM Patients

June 25, 2018

Aspirin did not affect cancer incidence in men, women, or those aged ≥65 years in subgroup analyses but there was a decrease in cancer incidence associated with aspirin use among those aged <65 years.

Many Childhood CA Survivors Not Concerned About Future Health

June 25, 2018

The researchers found that 31% of survivors were not concerned about their future health and that 40% were not concerned about developing cancer.

Palliative Care Reduces Odds of Suicide in Lung Cancer Patients

June 22, 2018

Only 20% of the patients who died by suicide had a palliative care encounter, compared with 57% among lung cancer patients whose cause of death was not suicide.