On December 9, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported it will highlight three scientific presentations related to its myRisk Hereditary Cancer test at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Myriad Genetics, DEC 9, 2015, View Source [SID:1234508518]). Data include results from studies that advance the understanding of hereditary cancer testing using multi-gene panels to evaluate patients at risk for or diagnosed with breast cancer.

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"Our collaborators will present data at SABCS this year that show multi-gene panel testing with myRisk Hereditary Cancer provides clinically significant results that drive appropriate changes in patient care," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Importantly, there are new data that demonstrate the positive perceptions from patients after they receive a multi-gene test result. Furthermore, as we expand our testing to broader gene panels and share scientific outcomes from our research collaborations, important new questions are being asked that will expand our thinking about exactly which patients should be tested for hereditary cancer."

Details about the featured myRisk Hereditary Cancer presentations at SABCS are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.

myRisk Hereditary Cancer Poster Presentations

Title: Interim analysis of multiplex gene panel testing for inherited susceptibility to breast cancer.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-01.
Presenter: Dr. Gregory Idos, Stanford University Cancer Institute.

This multi-center prospective study was designed to analyze data from 2,000 patients undergoing cancer-risk assessment using the myRisk Hereditary Cancer 25-gene panel test. The objective was to determine the benefits of multi-gene panel testing versus traditional genetic testing. The interim analysis of the first 332 patients tested found that 11 percent were positive for a deleterious mutation. Among participants testing negative for BRCA1 and BRCA2 mutations, the myRisk test identified deleterious mutations in 14 patients, representing a 61 percent increase over BRCA testing alone and prompting clinically appropriate risk reduction recommendations and enhanced cancer surveillance. These findings demonstrate the ability of the myRisk Hereditary Cancer test to identify a subset of patients with deleterious mutations who historically would have been missed by traditional genetic testing for BRCA1/2 alone, and who could receive appropriate medical management as a result.

Title: The patient experience in a prospective trial of multiple-gene panel testing for cancer risk.
Date: Thursday, Dec.10, 2015: 7:30 to 9:00 a.m. CT.
Location: Poster P2-09-07.
Presenter: Dr. Allison Kurian, Stanford University Cancer Institute

In this study, 2,000 diverse patients at risk for hereditary breast/ovarian cancer syndrome were evaluated to determine the patient experience following genetic testing with the myRisk Hereditary Cancer test. Patients were surveyed at entry and three months after testing using the Multidimensional Impact of Cancer Risk Assessment (MICRA) scale. An interim analysis of the first 332 patients found that 87 percent said they did not regret learning about the results and 81 percent wanted all their genetic test results for all 25 genes tested. Although the study is ongoing, these interim results suggest there is no evidence of an increase in cancer- or testing-related distress/uncertainty after patients received their test results.

Title: Predisposing germline mutations in an unselected academic breast cancer (BC) cohort.
Date: Wednesday, Dec. 9, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P1-08-07.
Presenter: Dr. Judy Garber, Dana-Farber Cancer Institute

In this study, 456 patients newly diagnosed with breast cancer were evaluated for mutations in 25 cancer genes using the myRisk Hereditary Cancer test. The results show that 11 percent of the patients in a single academic institution had a germline mutation in a breast cancer predisposition gene. Approximately 7 percent were in BRCA1/2 genes and 4 percent were in other cancer genes. Of the 49 women with deleterious mutations associated with breast cancer, 21 (43 percent) were diagnosed after age 45. This finding suggests that patients diagnosed with breast cancer at older ages may benefit from genetic testing with the myRisk Hereditary Cancer gene panel test.

For more information about these presentations, please visit the SABCS website at View Source

About Myriad myRisk Hereditary Cancer Testing

The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

On December 9, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO) and Eisai Inc. reported that they will present a scientific poster entitled, "Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN) in Triple Negative Breast Cancer Xenografts" at the 38th Annual San Antonio Breast Cancer Symposium (SABCS) on Dec. 9 (Press release, Halozyme, DEC 9, 2015, View Source [SID:1234508517]).

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The research showed the potential impact for PEGPH20-mediated hyaluronan (HA) removal on concentrations of eribulin and antitumor effects of breast cancer therapy in preclinical models. Halozyme’s investigational new candidate drug, PEGPH20 targets the degradation of HA, a glycosaminoglycan or chain of natural sugars that may accumulate in certain tumors.

Halozyme, a biotechnology company developing novel oncology and drug-delivery therapies, and Eisai Co., Ltd., the parent company of Eisai Inc., announced a clinical collaboration in July 2015, with plans to initiate a phase 1b/2 clinical trial to evaluate PEGPH20 plus eribulin in first-line HER2-negative metastatic breast cancer patients with high-HA tumors.

"Our preclinical studies have revealed important data about the potential for PEGPH20 when used in combination of eribulin, and we are looking forward to expanding on these important preclinical findings when we initiate our clinical study with Eisai," said Dr. Helen Torley, president and CEO of Halozyme. "We remain encouraged by the potential for PEGPH20 to help patients across a range of cancer and therapy types. Our presentation today reflects the growing body of research supporting this potential of PEGPH20."

"Data presented today highlight a productive preclinical collaboration with Halozyme and support Eisai’s commitment to address the unmet medical needs of patients with advanced breast cancer," said Alton Kremer, Deputy President, Oncology PCU and Chief Medical Officer, Global Oncology Business Unit, Eisai Inc. "We are encouraged by these preclinical data and look forward to enrolling patients in the clinical trial early next year."

SABCS Poster Presentation Details:

Poster Session:
P1-03-09, Wednesday, Dec. 9, 5:00 p.m. CT

About Eribulin Mesylate Injection (Available as HALAVEN in the United States)
The above publication does not necessarily contain information that is consistent with the U.S. prescribing information for HALAVEN (eribulin mesylate). It is an investigational use and there is no guarantee that this use will become available commercially.

HALAVEN (eribulin mesylate) injection is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Based on in vitro studies, eribulin exerts its effect via a tubulin-based antimitotic mechanism ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.

Important Safety Information
Neutropenia

Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days

Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels

Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received eribulin. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy

Patients should be monitored closely for signs of peripheral motor and sensory neuropathy
Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received eribulin. Delay administration of eribulin until resolution to Grade 2 or less
Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days)
Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation

Pregnancy Category D

Eribulin is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks
QT Prolongation

In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities
Correct hypokalemia or hypomagnesemia prior to initiating eribulin and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment

For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions

Most common adverse reactions (>25%) reported in patients receiving eribulin were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%)
The most common serious adverse reactions reported in patients receiving eribulin were febrile neutropenia (4%) and neutropenia (2%)

For more information about HALAVEN, click here for the full Prescribing Information.

On December 9, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the results from its Phase 3 clinical study of the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of melanoma patients with liver metastases, have been published in the December issue of the prestigious, peer-reviewed journal, Annals of Surgical Oncology (Press release, Delcath Systems, DEC 9, 2015, View Source;p=RssLanding&cat=news&id=2121277 [SID:1234508515]). The study completed enrollment in 2009 and used an earlier version of the Melphalan/HDS and procedure. Melphalan/HDS is investigational in the United States.

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The study, "Results of a Randomized Controlled Multi-Center Phase III Trial of Percutaneous Hepatic Perfusion (PHP) Compared to Best Available Care for patients with Melanoma Liver Metastases," by lead investigator and senior author James F. Pingpank, Jr., M.D., Associate Professor of Surgery at the University of Pittsburgh Medical Center, and first author Marybeth S. Hughes, M.D., Center for Cancer Research, National Cancer Institute, et al., compared patients randomly assigned to receive PHP treatments with melphalan using the Melphalan/HDS, or best alternative care (BAC). Patients assigned to the PHP arm were eligible to receive up to six cycles of treatment at approximately four to eight week intervals. Patients randomized to the BAC arm were permitted to cross-over into the PHP arm at radiographic documentation of hepatic disease progression; a majority of the patients in the BAC arm did, in fact, cross over to the PHP arm. Patients who received PHP were given stem cell support in the form of platelet and red blood cell infusions to mitigate toxic side effects of melphalan. The study’s primary endpoint was hepatic progression-free survival (hPFS); secondary endpoints included overall progression free survival (oPFS), overall survival (OS), hepatic objective response rate (hOR), and safety.

In the 93 patient study, results showed that patients in the PHP arm had a statistically significant longer median hPFS of 7.0 months compared to 1.6 months in the BAC control group, according to independent imaging review. Median oPFS was 5.4 months vs. 1.6 months for BAC, according to investigator assessment. Median OS for PHP was 10.6 months vs. 10 months for BAC; sub-group analysis revealed that OS among BAC patients who had crossed over to receive PHP was 13.1 months. The hOR was 36.4% for PHP vs. 2% for BAC. With the inclusion of patients with stable disease, overall hepatic disease control rates were 75% for PHP vs. 42.9% for BAC.

The most common post-procedure adverse events (AEs) were related to grade 3 and 4 bone marrow suppression, and included neutropenia (85.7%), thrombocytopenia (80%) and anemia (62.9%). Investigators attributed three deaths to treatment with PHP. An additional death resulting from a gastric perforation occurred in a patient that crossed-over to the PHP arm.

Investigators concluded that the study "demonstrated improved control of liver disease" in patients treated with Melphalan/HDS, and that the "benefit extended to oPFS", suggesting a clear clinical benefit to disease control in the liver in the patient population. Investigators noted that the earlier version of the Melphalan/HDS and PHP procedure utilized in the study was associated with significant morbidity, and recommended modifications such as the use of prophylactic bone marrow growth factors that are already required in the clinical studies that comprise Delcath’s current Clinical Development Program in the treatment of primary and metastatic liver cancers.

"Publication of the results of our prior Phase 3 trial in such a prestigious journal is a key milestone for Delcath, and underscores the importance of these data in this area of unmet medical need. In addition, it provides us with an important tool that will enhance our efforts to expand reimbursement in certain European countries," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "Since enrollment in this study was concluded in 2009, the number of treatments administered with the enhanced Melphalan/HDS product and procedure utilized commercially in Europe have exceeded the number treated during the trial. The more recent data from European experience presented at several medical congresses this fall provide us with confidence that an improved safety profile can be demonstrated in the new, pivotal global trial we expect to launch in the coming weeks."

On December 09, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that it will present a poster on Advaxis’s Lm Technology cancer immunotherapy ADXS-HER2 at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas during Poster Session 1 on Wednesday, December 9, 2015, from 5-7 p.m. CST (Press release, Advaxis, DEC 9, 2015, View Source [SID:1234508514]).

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"Standard treatments for metastatic HER2-positive breast cancer are effective, but resistance develops and different approaches are needed," said Antoinette R. Tan, M.D., M.H.Sc., Chief of Breast Medical Oncology at Levine Cancer Institute, Carolinas HealthCare System, Charlotte, N.C. "This Phase 1b trial tests the approach of using an attenuated bacteria that has been shown in preclinical studies to disable the tumor’s ability to hide from and resist therapy, potentially offering a novel therapeutic strategy for patients with HER2-positive tumors."

The poster, titled "A multicenter, Phase 1b, first-in-human dose-escalation study of ADXS31-164, a listeria monocytogenes-LLO immunotherapy, in patients with HER2-expressing solid tumors," will be presented by Dr. Tan. As of October 20, 2015, this study has enrolled three patients.

The Phase 1b study in humans builds upon efficacy and safety data from Phase 1 clinical studies of ADXS-HER2 conducted in dogs with osteosarcoma, which may have important translational relevance for human patients with osteosarcoma and other HER2 expressing cancers. Preliminary data from a Phase 1 clinical trial in companion dogs with spontaneous osteosarcoma showed that administration of ADXS-HER2 following amputation and chemotherapy was safe and induced immune responses against HER2 expressing tumors in 15 out of 18 dogs. Median survival times for ADXS-HER2 treated dogs and a matched historical control group were 956 days and 423 days respectively. Overall survival rates at 1 and 2 years for dogs treated with ADXS-HER2 were 77.8 percent and 67 percent respectively and 55 percent and 28 percent respectively for the historical control group. Based on these encouraging results, ADXS-HER2 is being considered for expedited approval in 2016 by the U.S. Department of Agriculture (USDA) to treat canine osteosarcoma.

Furthermore, preliminary data from a second ongoing canine Phase 1/2 trial suggests that ADXS-HER2 in combination with palliative radiation may delay primary and metastatic tumor progression and prolong overall survival in a subset of pet dogs with spontaneous osteosarcoma that do not undergo amputation or chemotherapy.

The European Medicines Agency (EMA) recently granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma in humans.

About HER2 Expressing Solid Tumor Cancers

Human epidermal growth factor receptor 2 (HER2) is overexpressed in a percentage of solid tumors such as breast, gastric, bladder, brain, pancreatic, ovarian and pediatric bone cancer (osteosarcoma). The American Cancer Society estimates that in 2015 in the United States alone there will be 231,840 new cases of invasive breast cancer; 24,590 new cases of gastric cancer; 74,000 new cases of bladder cancer; 22,850 new cases of brain/spinal cancer; 48,960 new cases of pancreatic cancer; 21,290 new cases of ovarian cancer; and 207 new cases of pediatric osteosarcoma. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival, and is an important target for immunotherapy.

About ADXS-HER2

ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.

Clinical trials of ADXS-HER2 have been placed on clinical hold by the FDA. Advaxis is working closely with the FDA and expects this clinical hold will be resolved expeditiously.

On December 9, 2015 Celgene Corporation (NASDAQ:CELG) reported that multiple studies being presented at the San Antonio Breast Cancer Symposium will highlight the investigational use of ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as neoadjuvant therapy in high-risk early breast cancer and in combination with a platinum in triple-negative breast cancer (Press release, Celgene, DEC 9, 2015, View Source [SID:1234508510]). Additionally, studies will evaluate ABRAXANE as a potential backbone of therapy with new immune-oncology agents.

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"The studies being presented at the San Antonio Breast Cancer Symposium this year support continued research into ABRAXANE as a taxane to combine with other agents in triple-negative breast cancer in both early and metastatic disease," said Jacqualyn A. Fouse, Ph.D., President, Hematology/Oncology for Celgene. "Our research efforts in this disease area underscore our ongoing commitment to patients who have few new therapeutic options."

Studies being presented include:

P1-14-11- New results from the neoadjuvant randomized GeparSepto study (GBG 69) of nab-paclitaxel at a dose of 125mg/m2 weekly compared to 150mg/m2 – December 9, 5 p.m. (Hall A-B).

P2-11-06 – Safety and clinical activity of atezolizumab (anti-PDL1) in combination with nab-paclitaxel in patients with metastatic triple-negative breast cancer – December 10, 7:30 a.m. (Hall A-B)

S6-07 – Comparison of 12 weeks neoadjuvant nab-paclitaxel combined with carboplatinum vs. gemcitabine in triple-negative breast cancer: WSG-ADAPT TN randomized phase II trial – December 11, 4:45 p.m. (Hall D)

To view all abstracts for studies being presented at the San Antonio Breast Cancer Symposium, visit View Source

ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Important Safety Information

WARNING – NEUTROPENIA

Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS

CONTRAINDICATIONS

Neutrophil Counts

ABRAXANE should not be used in patients who have baseline neutrophil counts of < 1500 cells/mm3
Hypersensitivity

Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug
WARNINGS AND PRECAUTIONS

Hematologic Effects

Bone marrow suppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In a clinical study, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC)

Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mm3
In the case of severe neutropenia ( < 500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with MBC

Resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level > 1500 cells/mm3 and platelets recover to > 100,000 cells/mm3

Nervous System

Sensory neuropathy is dose- and schedule-dependent
The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification
If ≥ Grade 3 sensory neuropathy develops, withhold until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE

Hypersensitivity

Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug

Hepatic Impairment

Because the exposure and toxicity of paclitaxel can be increased with hepatic impairment, administration of ABRAXANE in patients with hepatic impairment should be performed with caution
Patients with hepatic impairment may be at an increased risk of toxicity, particularly from myelosuppression, and should be monitored for development of profound myelosuppression
For MBC, the starting dose should be reduced for patients with moderate or severe hepatic impairment

Albumin (Human)

ABRAXANE contains albumin (human), a derivative of human blood
Use in Pregnancy: Pregnancy Category D

ABRAXANE can cause fetal harm when administered to a pregnant woman
If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus

Women of childbearing potential should be advised to avoid becoming pregnant while receiving ABRAXANE
Use in Men

Men should be advised not to father a child while receiving ABRAXANE

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, < 1%), nausea (any 30%, 22%; severe 3%, < 1%), diarrhea (any 27%, 15%; severe < 1%, 1%) and infections (24%, 20%), respectively

Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, < 1%), mucositis (any 7%, 6%; severe < 1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe < 1%, < 1%), neutropenic sepsis ( < 1%, < 1%), and injection site reactions ( < 1%, 1%), respectively. Dehydration and pyrexia were also reported

Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension

Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported
Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

Severe and sometimes fatal hypersensitivity reactions have been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting hypersensitivity to paclitaxel injection or to human albumin has not been studied
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE, primarily among individuals with underlying cardiac history or prior exposure to cardiotoxic drugs
There have been reports of extravasation of ABRAXANE. Given the possibility of extravasation, it is advisable to monitor closely the ABRAXANE infusion site for possible infiltration during drug administration

DRUG INTERACTIONS

Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4

USE IN SPECIFIC POPULATIONS

Nursing Mothers

It is not known whether paclitaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pediatric

The safety and effectiveness of ABRAXANE in pediatric patients have not been evaluated
Geriatric

A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years or older who received ABRAXANE for MBC in a pooled analysis of clinical studies
Renal Impairment

There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance < 30 mL/min)

DOSAGE AND ADMINISTRATION

Do not administer ABRAXANE to any patient with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN
Reduce starting dose in MBC patients with moderate to severe hepatic impairment
Dose reductions or discontinuation may be needed based on severe hematologic or neurologic toxicity
Monitor patients closely

Please see full Prescribing Information, including Boxed WARNING.