Oncology

Cancer, CV Risks Examined for Vaginal Estrogen Tx in Postmenopausal Women

By August 16, 2017

The data showed women with an intact uterus did not have a significantly different risk of stroke, invasive breast cancer, colorectal cancer, endometrial cancer, and pulmonary embolism/deep vein thrombosis (PE/DVT) between those who used vaginal estrogen and those who did not.

Cancer Rates Assessed Post-Endometrial Ablation

August 14, 2017

Leiomyomas, age younger than 35 years, at least 2 prior cesarean deliveries, and history of sterilization were factors that predisposed patients to post-ablation hysterectomy.

Accuracy of EBV DNA Examined as Nasopharyngeal CA Biomarker

August 10, 2017

Overall, 1.5% of all patients and 27.8% of those who initially tested positive had persistently positive results on the repeated sample four weeks later.

Tesevatinib Gains Orphan Drug Status for EGFR-Mutation Positive NSCLC

By August 07, 2017

In March 2016, tesevatinib was designated Orphan Drug status for the treatment of autosomal recessive polycystic kidney disease (ARPKD).

Vyxeos Approved for Two Types of Acute Myeloid Leukemia

By August 03, 2017

The approval was supported by data from a study in 309 patients (60-75 years of age) with newly diagnosed t-AML or AML-MRC who were randomized to either Vyxeos or daunorubicin and cytarabine separately.

Gene Variation May Affect Pharmacokinetics of Breast Cancer Treatment

August 03, 2017

"Our data suggest that the OATP1B1 c.521T>C SNP may influence exemestane pharmacokinetics in humans," the authors write.

Underlying Mechanisms ID'd in Curcumin Resensitization of CA Cells

August 02, 2017

The researchers reported the resensitization of chemoresistant PDAC cells by curcumin through inhibition of the PRC2-PVT1-c-Myc axis.

Periodontal Disease May Up Cancer Risk in Older Women

August 02, 2017

There was a correlation for periodontal disease history with increased total cancer risk.

Idhifa Approved for Relapsed/Refractory AML with IDH2 Mutation

By August 01, 2017

The drug carries a Boxed Warning regarding the risk of differentiation syndrome.

Opdivo Approved to Treat MSI-H or dMMR Metastatic Colorectal Cancer

By August 01, 2017

In the Phase 2, multicenter, open-label, single-arm CheckMate -142 trial (n=74), qualified patients received Opdivo 3mg/kg intravenously (IV) every 2 weeks.

Nerlynx Available for Extended Adjuvant Tx of HER2+ Early Stage Breast Cancer

By August 01, 2017

The approval was supported by data from the Phase 3 multicenter, randomized, double-blind, placebo-controlled ExteNET trial (n=2,840) following adjuvant treatment with trastuzumab.

Xatmep Now Available for Pediatric ALL, pJIA

By July 31, 2017

Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication.

Regular Thyroxine Use May Raise Thyroid Cancer Risk

July 31, 2017

Compared with controls, cases were more likely to have been previously diagnosed with hypothyroidism (adjusted odds ratio, 3.01).

Updated Prescribing Information for ChiRhoStim

By July 25, 2017

ChiRhoStim is available as 16mcg and 40mcg strength lyophilized powder in single-dose vials for reconstitution.

FDA Expands Yervoy Use for Pediatric Melanoma

By July 24, 2017

A population pharmacokinetic analysis (n=565) showed that Yervoy exposure in patients aged ≥12 years was similar to that in adults at the approved 3mg/kg dose given intravenously (IV) over 90 minutes every 3 weeks for a total of doses.

USPSTF Issues Draft Recommendation Statement on Ovarian Cancer Screening

July 21, 2017

Test isn't accurate enough to justify its use, U.S. Preventive Services Task Force says

Clinical Trial Enrollment Notably Increased for Privately Insured Under ACA

July 21, 2017

"This study is one piece of evidence that the ACA is helping more patients get access to these trials," said David Hong, MD, deputy chair of investigational cancer therapeutics at the University of Texas.

Long-Term Recurrence Assessed in Nipple-Sparing Mastectomies

July 20, 2017

At a median follow-up of 51 months, cancer recurrence developed in 17 patients. None of the recurrences involved nipples retained during mastectomies, the researchers found.

The Fruit That May Help Protect Skin From UV-Induced Damage

July 19, 2017

Compared to controls, the researchers found that male mice consuming red tomato diets or pooled tomato diets had significantly lower tumor number (1.73 ± 0.50 and 2.03 ± 0.45, respectively, versus 4.04 ± 0.65).

Nerlynx Approved to Reduce Risk of Breast Cancer Recurrence

By July 18, 2017

The invasive disease-free survival was reportedly 94.2% in Nerlynx-treated patients vs. 91.9% in placebo patients after 2 years (hazard ratio [HR] 0.66, 95% CI: 0.49, 0.90; P=0.008).

Diabetes Treatments Compared for Bladder Cancer Risk

By July 17, 2017

The greatest incidence of bladder cancer was among the group who initiated pioglitazone treatment, in which there were 308 cases per 100,000 person-years.

Pancreatic Enzyme Replacement Beneficial for Pancreatic Cancer Patients

By July 17, 2017

Data on nutritional markers (body mass index [BMI], albumin, total cholesterol) were collected at baseline and then assessed at 16 weeks; change from baseline was compared between the two groups.

FDA Committee in Favor of Herceptin Biosimilar Approval

By July 14, 2017

Herceptin, a human epidermal growth factor receptor (HER2) inhibitor, is currently approved to treat HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel in patients who have not received chemotherapy.

First Gene Therapy Drug Under FDA Expert Panel Review

July 13, 2017

The experimental gene therapy drug was developed by the University of Pennsylvania and Novartis and is called tisagenlecleucel (CTL019)

FDA Expands Blincyto Use for B-cell Precursor ALL

By July 12, 2017

The TOWER study (n=405) demonstrated a superior improvement in median OS with Blincyto vs. standard of care (SOC) chemotherapy (7.7 months vs. 4 months, hazard ratio [HR] 0.71; P=0.012).

FDA Committee in Favor of Mylotarg for AML

By July 12, 2017

The Food and Drug Administration's Oncologic Drug Advisory Committee has voted in favor that the data from ALFA-0701 has shown a favorable risk-to-benefit for Mylotarg as add-on to chemotherapy for patients with newly diagnosed CD33-positive acute myeloid leukemia.

Strong Link Identified Between Parkinson's and Melanoma

July 11, 2017

The researchers found that, compared with controls, patients with Parkinson's disease had a 3.8-fold increased likelihood of having preexisting melanoma, while patients with melanoma had a 4.2-fold increased risk of developing Parkinson's disease.

Cancer Peptide Vaccine Designated Orphan Drug for MDS

By July 10, 2017

Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.

Advanced Breast Cancer Drug Granted Priority Review

By July 10, 2017

The NDA included data from two trials, MONARCH 1 and MONARCH 2, which are a part of the comprehensive MONARCH clinical trial program.

Entrectinib Gains Orphan Drug Status for NTRK Fusion(+) Tumors

By July 10, 2017

Currently, entrectinib is being evaluated in the global, multicenter, open-label, potentially registration-enabling Phase 2 STARTRK-2 trial (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases)