Drug Information

Encorafenib, Binimetinib Combination Receives FDA Approval for Mutation-Positive Melanoma

Encorafenib, Binimetinib Combination Receives FDA Approval for Mutation-Positive Melanoma

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Approval was granted for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.

Interim Data Shows Romiplostim May Lead to Positive Long-Term Response in Pediatric ITP

Interim Data Shows Romiplostim May Lead to Positive Long-Term Response in Pediatric ITP

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In a poster presentation at the 23rd Congress of EHA, researchers described a study of the efficacy of romiplastim in achieving a platelet response in pediatric patients with immune thrombocytopenia.

First Antibody-Based Treatment Regimen Approved for First-Line Treatment of Multiple Myeloma

First Antibody-Based Treatment Regimen Approved for First-Line Treatment of Multiple Myeloma

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The 18-month progression-free survival rate was 71.6% among patients treated with daratumumab plus VMP compared with 50.2% among patients treated with VMP alone.

Dual Inhibitor for Treating CLL/SLL, Follicular Lymphoma Granted Priority Review

Dual Inhibitor for Treating CLL/SLL, Follicular Lymphoma Granted Priority Review

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Duvelisib, a first-in-class dual inhibitor of PI3K-delta and -gamma, was evaluated in patients with relapsed/refractory CLL/SLL and in patients with refractory indolent non-Hodgkin lymphoma.

Patient Advocacy, Questioning 'Status Quo,' Improves Safety in Ambulatory Infusion Setting

Patient Advocacy, Questioning 'Status Quo,' Improves Safety in Ambulatory Infusion Setting

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In fielding reports of CNS-related adverse effects from patients in the ambulatory infusion room, nurses were able to prompt a pharmacy practice review. The outcomes of the resulting switch in premedication for HSR was presented at the 2018 ONS Annual Congress.

Rucaparib Granted FDA Approval for Some Recurring Abdominal Cancers

Rucaparib Granted FDA Approval for Some Recurring Abdominal Cancers

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The US FDA granted approval based on results from ARIEL3, a randomized clinical trial conducted with 561 eligible cancer patients.

FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence

FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence

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Accelerated approval was granted by the FDA based on the results of a single-arm trial.

Dabrafenib-Trametinib Combination Approved for Mutation-Positive Thyroid Cancer

Dabrafenib-Trametinib Combination Approved for Mutation-Positive Thyroid Cancer

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FDA grants approval to immunotherapy combination in the treatment of unresectable and metastatic BRAF V600E mutation-positive anaplastic thyroid cancer (ATC).

Recruitment for 2 Trials of Investigational ADC for Urothelial Cancer Underway

Recruitment for 2 Trials of Investigational ADC for Urothelial Cancer Underway

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Enfortumab vedotin was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA), based on interim results from a Phase 1 study.

Moderately Emetogenic Chemotherapy Drug Demonstrates High Emetogenic Potential

Moderately Emetogenic Chemotherapy Drug Demonstrates High Emetogenic Potential

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Based on results of a prospective and retrospective study evaluating emetogenic potential of 50 chemotherapeutic regimens, researchers suggest changing the classification of irinotecan.

FDA Approves Fostamatinib for ITP After Insufficient Response to Previous Treatment

FDA Approves Fostamatinib for ITP After Insufficient Response to Previous Treatment

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The US FDA granted approval to fostamatinib (Tavalisse), a kinase inhibitor, for the treatment of thrombocytopenia in patients with chronic IPT who have had an insufficient response to a previous treatment.

National Cancer Drug Shortages Unknown to Many Patients

National Cancer Drug Shortages Unknown to Many Patients

A majority of study respondents reported wanting to be informed about the differences in a drug substitution's efficacy or side effects.

Olanzapine Use to Prevent Chemotherapy-Induced Nausea and Vomiting

Olanzapine Use to Prevent Chemotherapy-Induced Nausea and Vomiting

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Why is the antipsychotic olanzapine (Zyprexa) being used to prevent nausea?

Blinatumomab Indications Expanded to Include MRD+-B-Cell Precursor ALL

Blinatumomab Indications Expanded to Include MRD+-B-Cell Precursor ALL

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The US FDA approved expanding the indications for the agent to include pediatric and adult patients with B-cell precursor ALL who have minimal residual disease during or after treatment.

Promising Phase 2 Results Lead to Fast Track Designation for Pancreatic Cancer Drug 

Promising Phase 2 Results Lead to Fast Track Designation for Pancreatic Cancer Drug 

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FDA Fast Track designation was supported by data from a Phase 2 study reviewing pamrevlumab in combination with gemcitabine and nab-paclitaxel.

Ciprofloxacin Plus Doxycycline Reduces Infection Rate in Multiple Myeloma Post-ASCT

Ciprofloxacin Plus Doxycycline Reduces Infection Rate in Multiple Myeloma Post-ASCT

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A health outcomes analysis of 419 patients with multiple myeloma sought to determine if cipro-doxy was more effective than cipro alone in reducing the incidence of neutropenic fever and infections, both significant causes of morbidity and death for these patients.

Modified XELIRI Noninferior to FOLFIRI for OS in Metastatic Colorectal Cancer

Modified XELIRI Noninferior to FOLFIRI for OS in Metastatic Colorectal Cancer

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Results of the phase 3 AXEPT study were used to determine the noninferiority of a modified XELIRI regimen vs a FOLFIRI regimen in terms of overall survival among patients with metastatic colorectal cancer (mCRC).

Oral Androgen Receptor Inhibitor Granted FDA Approval for Nonmetastatic CRPC

Oral Androgen Receptor Inhibitor Granted FDA Approval for Nonmetastatic CRPC

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According to the FDA, the drug approval is the first to use the end point of metastasis-free survival.

FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages

FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages

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What is being done to address shortages of chemotherapy drugs?

FDA Upgrades Nivolumab to Regular Approval for Adjuvant Treatment of Advanced Melanoma

FDA Upgrades Nivolumab to Regular Approval for Adjuvant Treatment of Advanced Melanoma

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The FDA granted approval for nivolumab for adjuvant treatment of some patients with melanoma, based on the results of the CHECKMATE-238 study.

US Pharmacopeia Revises Chapter on Handling Hazardous Drugs

US Pharmacopeia Revises Chapter on Handling Hazardous Drugs

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What is the USP and what do I need to know about it as an oncology nurse?

Priority Review of New Drug Application Granted to Apalutamide for CRPC

Priority Review of New Drug Application Granted to Apalutamide for CRPC

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Data from the phase 3 SPARTAN trial prompted the FDA's Priority Review designation for apalutamide.

FDA Issues Warning for Rolapitant Injectable Emulsion in the Treatment of CINV

FDA Issues Warning for Rolapitant Injectable Emulsion in the Treatment of CINV

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FDA issues black box warning for rolapitant regarding the potential for anaphylaxis, anaphylactic shock, and other hypersensitivity reactions in patients receiving the injectable emulsion for CINV prophylaxis.

Dietary Estrogens Reduced Efficacy of Novel Breast Cancer Therapy

Dietary Estrogens Reduced Efficacy of Novel Breast Cancer Therapy

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A metabolomics study of the effect of palbociclib/letrozole combination on cancer cells discovered that consumption of foods with certain xenoestrogens has a negative effect on the treatment.

Indications for Cabozantinib in Advanced RCC Expanded to First-line Therapy

Indications for Cabozantinib in Advanced RCC Expanded to First-line Therapy

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The FDA based its approval on data collected from the open-label, phase 2 CABOSUN study, for which researchers randomly assigned 157 patients with RCC to receive oral cabozantinib or sunitinib.

FDA Grants Breakthrough Therapy Designation to Ribociclib for HR+/HER2- Breast Cancer

FDA Grants Breakthrough Therapy Designation to Ribociclib for HR+/HER2- Breast Cancer

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FDA grants Breakthrough Therapy designation for ribociclib as an initial endocrine-based therapy for HR+/HER2- breast cancer in premenopausal or perimenopausal women.

Venetoclax Effective in Ibrutinib-Failed Chronic Lymphocytic Leukemia

Venetoclax Effective in Ibrutinib-Failed Chronic Lymphocytic Leukemia

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The efficacy and safety of venetoclax in patients with relapsed/refractory CLL that progressed during or after ibrutinib therapy was determined in an open-label, phase 2 study.

ASHP and Partners Urge Congress to Action on Drug Shortages

ASHP and Partners Urge Congress to Action on Drug Shortages

Groups urge Congress to take immediate action, provide transparency, and improve drug manufacturing.

FDA Approves Biosimilar Trastuzumab-dkst for Breast and Stomach Cancers

FDA Approves Biosimilar Trastuzumab-dkst for Breast and Stomach Cancers

Ogivri was granted FDA approval to treat HER2 breast and gastric or gastroesophageal junction adenocarcinoma cancers.

Opioid Epidemic Response May Be Limiting Cancer-Related Pain Management

Opioid Epidemic Response May Be Limiting Cancer-Related Pain Management

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A report on current legislation and practice trends regarding opioids and how they are affecting cancer patients' ability to manage their pain.

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