What's in a Label? Radioimmunotherapy for Metastatic Prostate Cancer

“Prostate cancer has a highly tumor-restricted prostate-specific membrane antigen (PSMA) and may be the ideal solid-organ malignancy for treatment with radioimmunotherapy. Encouraging results using lutetium-177-labeled anti-PSMA monoclonal antibody J591 from a Phase II study by Tawaga et al. support the continued clinical and preclinical development of radioimmunotherapy for solid tumors.”


Toward Patient-Centered Drug Development in Oncology

“As an oncologist, when I sit with patients to discuss starting a new chemotherapy regimen, their first questions are often “How will it make me feel?” and “How did patients like me feel with this treatment?” Regrettably, this information is generally missing from U.S. drug labels and from published reports of clinical trials — the two information sources most commonly available to people trying to understand the clinical effects of cancer drugs. In 2011, 15 hematology–oncology drugs were approved by the U.S. Food and Drug Administration (FDA). In only one case — that of ruxolitinib for the management of myelofibrosis — was symptom information included in the portion of the label that manufacturers can legally use for marketing purposes. In fact, ruxolitinib was the first cancer therapeutic in more than a decade for which symptom information was included in a U.S. drug label.”


Toward Patient-Centered Drug Development in Oncology

“As an oncologist, when I sit with patients to discuss starting a new chemotherapy regimen, their first questions are often “How will it make me feel?” and “How did patients like me feel with this treatment?” Regrettably, this information is generally missing from U.S. drug labels and from published reports of clinical trials — the two information sources most commonly available to people trying to understand the clinical effects of cancer drugs. In 2011, 15 hematology–oncology drugs were approved by the U.S. Food and Drug Administration (FDA). In only one case — that of ruxolitinib for the management of myelofibrosis — was symptom information included in the portion of the label that manufacturers can legally use for marketing purposes. In fact, ruxolitinib was the first cancer therapeutic in more than a decade for which symptom information was included in a U.S. drug label.”


Toward Patient-Centered Drug Development in Oncology

“As an oncologist, when I sit with patients to discuss starting a new chemotherapy regimen, their first questions are often “How will it make me feel?” and “How did patients like me feel with this treatment?” Regrettably, this information is generally missing from U.S. drug labels and from published reports of clinical trials — the two information sources most commonly available to people trying to understand the clinical effects of cancer drugs. In 2011, 15 hematology–oncology drugs were approved by the U.S. Food and Drug Administration (FDA). In only one case — that of ruxolitinib for the management of myelofibrosis — was symptom information included in the portion of the label that manufacturers can legally use for marketing purposes. In fact, ruxolitinib was the first cancer therapeutic in more than a decade for which symptom information was included in a U.S. drug label.”


Survival for Advanced Prostate Cancer 'Triples' for Men on Trials

Men with advanced, incurable prostate cancer who are treated with the latest drugs have nearly three times the life expectancy of men treated a decade ago, according to data from the Royal Marsden Hospital in the UK. Men who were treated in trials or under drug access schemes at the hospital survived 41 months on average, compared with between 13 and 16 months, 10 years ago. All had prostate cancer, which had spread and no longer responded to standard hormone treatments. Just over three-quarters of the patients received a chemotherapy drug called docetaxel, which was approved for National Health Service (NHS) use in 2005.


Afatinib is FDA-Approved: What It Means For NSCLC Patients


On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.

EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…


Aflibercept: Another Targeted Drug Fails in Prostate Cancer

“The addition of the targeted angiogenesis inhibitor aflibercept (Zaltrap, Regeneron/Sanofi) to chemotherapy did not prolong overall survival in men with metastatic castration-resistant prostate cancer (CRPC),” according to the phase III VENICE trial. The results, published in the July issue of Lancet Oncology, are not that surprising. There have been at least seven large, phase III trials in which a targeted agent was added to chemotherapy with docetaxel in CRPC. All have been unsuccessful. “Despite a substantial expenditure in terms of patients’ time and financial resources, none of these trials have shown an improvement in survival beyond that achieved with docetaxel alone,” write Michael Galsky, MD, and William Oh, MD, from the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, in an accompanying comment.”


A Phase II Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) in Pretreated Patients with Small-Cell Lung Cancer

“Background: In vitro data suggest that panobinostat (LBH589), a pan-deacetylase inhibitor, may add therapeutic benefit in the treatment of small-cell lung cancer (SCLC) with regression. Methods: This multicenter, nonrandomized phase 2 trial was designed to evaluate antitumor activity of LBH589 in patients with previously treated SCLC. Patients received LBH589 administered intravenously at a dose of 20 mg/mq (days 1-8) every 21 days.”


A Randomized Phase II Trial of Multiepitope Vaccination with Melanoma Peptides for Cytotoxic T Cells and Helper T Cells for Patients with Metastatic Melanoma (E1602)

“Purpose: This multicenter randomized trial was designed to evaluate whether melanoma helper peptides augment cytotoxic T lymphocyte (CTL) responses to a melanoma vaccine and improve clinical outcome in patients with advanced melanoma. Experimental Design: One hundred seventy-five patients with measurable stage IV melanoma were enrolled into 4 treatment groups, vaccinated with 12 MHC class I-restricted melanoma peptides to stimulate CTL (12MP, group A), plus a tetanus peptide (group B), or a mixture of 6 melanoma helper peptides (6MHP, group C) to stimulate helper T lymphocytes (HTL), or with 6 melanoma helper peptide (6MHP) alone (group D), in incomplete Freund’s adjuvant plus granulocyte macrophage colony-stimulating factor. CTL responses were assessed using an in vitro-stimulated IFN-γ ELIspot assay, and HTL responses were assessed using a proliferation assay.”