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January 7, 2019
Roche’s Tecentriq Wins Speedy U.S. FDA Review for Small Cell Lung Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.
“The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone.
“Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.”
Go to full article published by Reuters on Dec 4, 2018.
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December 18, 2018
New HERizons: HER2-Positive Breast Cancer and the Legacy of Herceptin
Emma Shtivelman, PhDTwenty years ago, no targeted treatments existed for breast cancers with high levels of a protein called HER2 (HER2-positive, or HER2+). The significance of HER2 in breast cancer had only been recognized in 1987, when excessive levels of the protein were identified in about 20% of breast cancers. Oncologists realized that high levels of HER2 mark a type of cancer with a poor prognosis,… Read more »
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December 12, 2018
How Can We Unleash the Immune System? Bookmark
Emma Shtivelman, PhDExcerpt:
“Cancer has an insidious talent for evading the natural defenses that should destroy it. What if we could find ways to help the immune system fight back?
“It has begun to happen. The growing field of immunotherapy is profoundly changing cancer treatment and has rescued many people with advanced malignancies that not long ago would have been a death sentence.”
Go to full article published by The New York Times on Nov 19, 2018.
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December 12, 2018
FDA Approves Lorlatinib for Second- or Third-Line Treatment of ALK-Positive Metastatic NSCLC Bookmark
Emma Shtivelman, PhDExcerpt:
“On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
“Approval was based on a subgroup of 215 patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK kinase inhibitors, enrolled in a non‑randomized, dose-ranging and activity-estimating, multi‑cohort, multicenter study (Study B7461001; NCT01970865). The major efficacy measures were overall response rate (ORR) and intracranial ORR, according to RECIST 1.1, as assessed by an independent central review committee.”
Go to full article published by the U.S. Food and Drug Administration on Dec 14, 2018.
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December 12, 2018
Pembrolizumab Regimen Receives FDA Approval for Frontline Treatment of Squamous NSCLC Bookmark
Emma Shtivelman, PhDExcerpt:
“Based on findings from the phase III KEYNOTE-407 trial, pembrolizumab (Keytruda) has been approved by the FDA for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the frontline treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC).
“Results from the trial showed combining pembrolizumab with chemotherapy reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous NSCLC. The median overall survival (OS) was 15.9 months (95% CI, 13.2 – not evaluable) with pembrolizumab versus 11.3 months (95% CI, 9.5-14.8) with chemotherapy alone (HR, 0.64; 95% CI, 0.49-0.85; P = .0017). The OS benefit was observed regardless of PD-L1 expression level, choice of taxane, age, sex, and ECOG performance status.”
Go to full article published by Targeted Oncology on Oct 30, 2018.
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November 20, 2018
Prostatectomy Plus Radiotherapy May Improve Survival in Advanced Prostate Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“Patients who underwent primary radical prostatectomy followed by radiotherapy for locally or regionally advanced prostate cancer had better survival outcomes than patients treated with radiotherapy plus androgen deprivation therapy, according to findings from a population-based, retrospective study published in Cancer.
” ‘There is a lot of debate about whether to remove the whole prostate and follow-up with radiation therapy or, as a second option, spare the prostate and treat it using radiation therapy plus hormone-blocking therapy,’ Grace Lu-Yao, PhD, associate director of population science at the Sidney Kimmel Cancer Center at Jefferson Health, said in a press release. ‘Our study suggests that removing the prostate followed by adjuvant radiotherapy is associated with greater OS in men with prostate cancer.’ ”
Go to full article published by Healio on Oct 15, 2018.
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November 20, 2018
FDA Approves Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
“Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.”
Go to full article published by the U.S. Food and Drug Administration on Oct 16, 2018.
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November 13, 2018
The Promise of Plerixafor in Glioblastoma Treatment
With:A Q&A with Adan Rios, MD; Professor in the Division of Oncology-Department of Internal Medicine of The University of Texas McGovern Medical School at Houston, Texas Medical Center; adan.rios@uth.tmc.edu Q: Glioblastoma multiforme (GBM) remains a scourge with a typically rapid fatal course resistant to most therapy. All solid tumors must receive sufficient blood supply to grow. Plerixafor is an FDA-approved drug that may inhibit… Read more »
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October 22, 2018
Groups Endorse Shorter RT for Prostate Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“Hypofractionated external beam radiation therapy (EBRT) for early prostate cancer represents a reasonable alternative to standard treatment protocols involving lower doses of radiation administered over a longer period of time, according to a new clinical guideline.
” ‘Moderately hypofractionated’ EBRT regimens result in similar disease control and side effects as compared with conventional protocols, although the shortened regimens confer a small risk of more short-term gastrointestinal toxicity. Additionally, physicians should counsel patients about the limited data on oncologic outcomes beyond 5 years of follow-up, according to a panel representing the American Society for Radiation Oncology, American Society of Clinical Oncology, and American Urological Association.”
Go to full article published by MedPage Today on Oct 11, 2018.
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October 22, 2018
Immunotherapy Effective Against Hereditary Melanoma Bookmark
Emma Shtivelman, PhDExcerpt:
“Individuals with an inherited form of skin cancer often have a poor prognosis. The type of immunotherapy that was awarded this year’s Nobel Prize in Physiology or Medicine is, however, particularly effective in this patient group, research from Karolinska Institutet in Sweden shows. The study is published in the Journal of Medical Genetics.
“Congenital mutations of the CDKN2A gene are the strongest known risk factors for inherited skin cancer. Individuals with melanoma who carry mutations in this gene also have poor prognosis, according to previous research.”
Go to full article published by Medical Xpress on Oct 8, 2018.
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