Formulary Watch |

Experts discuss rules for access to experimental drugs

The extent to which patients should have access to experimental therapies is a hotly contested issue, and courts and regulatory agencies have wrestled with the problems involved when an individual is willing to be treated with unapproved drugs at the potential expense of causing harm not only to the individual but to the clinical trial process itself.

Concomitant medications, aging-related changes in drug distribution may be predictors of chemotherapy adverse events in elderly patients with cancer

Drug-drug and disease-drug interactions in elderly patients with cancer are significant; 33% of elderly patients who are taking 3 or more medications are rehospitalized within 6 months of a hospital discharge. "A better index of predicting tolerance to chemotherapy in the elderly is crucial," said Mihaela Popa, MD, Moffitt Cancer Center, Tampa, Florida. Tolerance to chemotherapy among older patients with cancer may be affected by multiple chronic conditions requiring multiple medications and aging-related alterations that induce changes in drug distribution, she said.

KRAS gene status predicts response to initial biologic treatment for colorectal cancer

Patients with metastatic colorectal cancer are more likely to respond to initial treatment that includes cetuximab if they have nonmutated, wild-type KRAS gene status, reported Eric Van Cutsem, MD, University Hospital Gasthuisberg, Leuven, Belgium. "For the first time in colorectal cancer, we are able to predict which patients are likely to be helped by the new biologics," he said. "KRAS is the first molecular marker for the selection of a targeted therapy in combination with a standard chemotherapy regimen in first-line metastatic colorectal cancer. KRAS testing should be routinely conducted in all colorectal cancer patients immediately after diagnosis to ensure the best treatment strategies for the individual patient."

Review of inhaled corticosteroid/long-acting beta2-agonist combinations

In an effort to simplify therapy for patients with asthma or COPD, products have been designed that combine medications from 2 separate therapeutic classes.

Electronic medication management system available to improve medication adherence

In June 2007, FDA approved an Electronic Medication Management Assistant (EMMA) device and electronic medication administration record (eMAR) to help combat problems involving drug identification and dosing.

Glatiramer, interferon beta-1b comparable in early RRMS

An investigational 500-mcg dose of interferon beta-1b demonstrated no advantage compared with the approved 250-mcg dose of interferon beta-1b or with glatiramer 20 mg in reducing relapse risk in patients with early relapsing-remitting multiple sclerosis (RRMS), said Paul O'Connor, MD, MS Program Director, St. Michael's Hospital, the University of Toronto, at the 60th Annual Meeting of the American Academy of Neurology, Chicago.

Lacosamide decreases diabetic neuropathic pain

Lacosamide safely decreases pain scores in patients with painful diabetic neuropathy, according to a pooled efficacy and safety analysis presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago.

Glatiramer effective in delaying clinical MS

Glatiramer represents a new option for delaying conversion of clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (CDMS), according to the results of a new study known as PRECISE, presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago.

Iloperidone: A novel atypical antipsychotic for the treatment of schizophrenia

Iloperidone, a new-generation atypical antipsychotic, is currently under investigation for the treatment of schizophrenia. In 4 separate phase 3 trials, iloperidone has demonstrated efficacy in treating schizophrenia, with total Positive and Negative Symptom Scale (PANSS) scores decreasing by a range of 8 to 14 points depending on the iloperidone dose.

First-time generic drug approvals, June 2008

Generic drugs approved by FDA (through June 2008) including epoprostenol for injection, ropinirole, donepezil, and drospirenone/ethinyl estradiol.

FDA Pipeline preview, June 2008

Recent FDA action (through June 2008) related to lucinactant, loratadine/montelukast, niacin/laropiprant, fentanyl buccal, NPL-2008, carfilzomib, resveratrol, and rhitol.

FDA actions in brief, June 2008 (Rotarix, Pantanase, Treximet, Aplenzin, Relistor, Actonel, Vyvanse, Advair Diskus 250/50, Orencia)

Recent FDA approvals and indications (through June 2008) related to Rotarix, Pantanase, Treximet, Aplenzin, Relistor, Actonel, Vyvanse, Advair Diskus 250/50, and Orencia.

Lubiprostone (Amitiza): Chloride channel activator approved for the treatment of irritable bowel syndrome with constipation

New indication: Lubiprostone (Amitiza), a chloride channel activator, was approved on April 29, 2008, for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged at least 18 years.

Certolizumab pegol (Cimzia): Tumor necrosis factor blocker approved for the treatment of moderate-to-severe Crohn's disease

New biologic: Certolizumab pegol (Cimzia), a tumor necrosis factor blocker, was approved on April 22, 2008, for the reduction of the signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Blood assay may detect early lung cancer

An RNA signature present in blood that is highly accurate for detecting prevalent lung cancer can accurately predict the development of lung cancer within the next 2 years 80% of the time, said Thomas Zander, MD, Department of Internal Medicine and the Center for Integrated Oncology, University Clinic Cologne, Germany. "Early detection of lung cancer is a major need, as most patients present for diagnosis at a late stage when there is no chance for cure," Dr Zander said. Two-year survival after a lung cancer diagnosis is approximately 15%. Early detection may therefore be a promising strategy to improve survival rates.

Acupuncture demonstrates promise in treating symptoms after neck dissection

A small study suggests that acupuncture has the potential to reduce pain and dysfunction in patients with head and neck cancer who have undergone neck dissection, said David G. Pfister, MD, chief, Head and Neck Medical Oncology, Memorial Sloan Kettering Cancer Center, New York.

High-dose vitamin D relieves pain and fatigue associated with aromatase inhibitor therapy

High-dose vitamin D supplementation can provide relief of symptoms related to vitamin D deficiency from aromatase inhibitor therapy in postmenopausal women with breast cancer, said Q.J. Khan, MD, Cancer Center of Kansas, Wichita.

Combined treatment benefits elderly patients with lung cancer

Most elderly patients do not receive combined modality treatment (CMT) with both chemotherapy and radiation for locally advanced, non-small cell lung cancer (NSCLC) despite trial data indicating that CMT enhances survival, decreases comorbidities, and is potentially curative. Data presented by Martin J. Edelman, MD, professor of medicine, University of Maryland Greenebaum Cancer Center, Baltimore, indicate that elderly patients receiving chemotherapy followed by concurrent chemotherapy and radiation derive the most significant survival benefit.

Use of ESAs should be restricted to indications, experts say

Strict evidence-based criteria should be used when prescribing erythropoiesis-stimulating agents (ESAs) for cancer, as ESAs appear to activate signaling pathways that are important in altering tumor behavior and treatment response, experts said.

Experts discuss rules for access to experimental drugs

The extent to which patients should have access to experimental therapies is a hotly contested issue, and courts and regulatory agencies have wrestled with the problems involved when an individual is willing to be treated with unapproved drugs at the potential expense of causing harm not only to the individual but to the clinical trial process itself.

Concomitant medications, aging-related changes in drug distribution may be predictors of chemotherapy adverse events in elderly patients with cancer

Drug-drug and disease-drug interactions in elderly patients with cancer are significant; 33% of elderly patients who are taking 3 or more medications are rehospitalized within 6 months of a hospital discharge. "A better index of predicting tolerance to chemotherapy in the elderly is crucial," said Mihaela Popa, MD, Moffitt Cancer Center, Tampa, Florida. Tolerance to chemotherapy among older patients with cancer may be affected by multiple chronic conditions requiring multiple medications and aging-related alterations that induce changes in drug distribution, she said.

KRAS gene status predicts response to initial biologic treatment for colorectal cancer

Patients with metastatic colorectal cancer are more likely to respond to initial treatment that includes cetuximab if they have nonmutated, wild-type KRAS gene status, reported Eric Van Cutsem, MD, University Hospital Gasthuisberg, Leuven, Belgium. "For the first time in colorectal cancer, we are able to predict which patients are likely to be helped by the new biologics," he said. "KRAS is the first molecular marker for the selection of a targeted therapy in combination with a standard chemotherapy regimen in first-line metastatic colorectal cancer. KRAS testing should be routinely conducted in all colorectal cancer patients immediately after diagnosis to ensure the best treatment strategies for the individual patient."

Drug Watch: Agents in late-stage development for the treatment of bipolar disorder and psychosis (June 2008) (PDF)

Drugs in development for the treatment of bipolar disorder and psychosis

Adjuvant Zoledronic Acid Decreases Breast Ca Recurrence in Premenopausal Women

Adding zoledronic acid to anastrozole or tamoxifen therapy decreased recurrence by 35% and increased disease free survival by 36% in premenopausal breast cancer patients, according to results of the Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12). The multicenter, Phase III trial is the first large trial to demonstrate the significant antitumor benefit of zoledronic acid, said Michael Gnant, MD, Medical University of Vienna. "Adjuvant treatment with zoledronic acid should be considered in order to improve the standard of care in premenopausal breast cancer patients," he said.

Modafinil appears to alleviate chemotherapy-induced fatigue

Modafinil appears to reduce the severity of chemotherapy-induced severe fatigue, reported Gary R. Morrow, PhD, MS.

Vaginal Brachytherapy Is Effective, has Fewer Side Effects, Gives Better Quality of Life

Vaginal brachytherapy is as effective as external beam radiation therapy in preventing the recurrence of higher-risk endometrial cancer but with fewer side effects and results in superior quality of life, according to a Phase 3 study presented by Remi A. Nout, MD.

Intervention Program Improves Sleep Quality During Chemotherapy

Adherence to a four-point Individualized Sleep Promotion Plan (ISPP) intervention consisting of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene practices significantly lowered fatigue and increased sleep quality for patients undergoing adjuvant chemotherapy. Fatigue and sleep disturbances are the most frequently reported symptoms during adjuvant chemotherapy for breast cancer. One-third of breast cancer patients report persistent fatigue and abnormal sleep/wake cycles, said Ann M Berger, PhD, RN, professor, College of Nursing, University of Nebraska Medical Center, Omaha.

Sunitinib Recipients Should Receive Cardiac Monitoring

Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.

Everolimus may Be Effective Second-line Option After Failure of First-line Tx in Renal-cell Ca

Everolimus, an experimental oral agent that targets the mTOR protein, may represent an effective second-line option for patients with metastatic renal-cell carcinoma whose disease has progressed despite treatment with a tyrosine kinase inhibitor.

Bevacizumab, docetaxel combination is effective first-line treatment for metastatic breast cancer

Phase 3 trial results show that adding bevacizumab to docetaxel as first-line therapy for newly diagnosed HER2-negative, locally recurrent, or metastatic breast cancer resulted in significantly less disease progression. "This shows that the antiangiogenic approach to treating breast cancer is effective, regardless of which taxane drug it is combined with," said lead author David Miles, MD, professor, Mount Vernon Cancer Center, Middlesex, UK. Previous studies have shown that the combination of bevacizumab to paclitaxel doubled progression-free survival among patients with metastatic breast cancer.