Entries by News Feed

MURANO trial Results Demonstrate PFS Benefit with Venetoclax/Rituximab

According to findings from the Phase 3 MURANO trial recently published in the New England Journal of Medicine, the venetoclax (Venclexta) plus rituximab (Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia. Read full article […]

Bendell Takes the Helm as Chief Development Officer at Sarah Cannon

Internationally renowned expert, Johanna C. Bendell, MD, has been promoted to chief development officer at Sarah Cannon. Her title responsibilities include developing and expanding physician, site, and Pharma relationships across the Sarah Cannon Network, thereby expanding the organization’s efforts to bring more qualitative treatment options to its patients. Read full article (External website)

Expert Discusses Potential Expansions to the Treatment Landscape in RCC

Treatment of renal cell carcinoma (RCC) is awaiting the potential integration of combinations of immuno-oncology agents like nivolumab (Opdivo) and ipilimumab (Yervoy), or combinations of targeted therapies with checkpoint inhibitors into the treatment paradigm. In an interview with Targeted Oncology, Robert A. Figlin, MD, discusses the expanding RCC armamentarium and balancing the benefits and risks […]

Priority Review Granted by FDA for Nivolumab Plus Ipilimumab Combo for MSI-H/dMMR CRC

There has been a supplemental biologics license application (sBLA) granted priority review by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases of metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan. Read full article […]

EMA Suggests Extension of Therapeutic Indications for Denosumab

Extension of indication includes the avoidance of skeletal-related events in grown-ups with late-stage malignancies involving the bone On 22 February 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending towards a change in the marketing authorisation for denosumab (licensee: Amgen Europe BV). The following extension of […]

Promise Seen With Frontline Pembrolizumab Plus Chemotherapy in Ovarian Cancer

The combination of first-line platinum-containing chemotherapy plus the anti-PD-1 agent pembrolizumab (Keytruda), followed by pembrolizumab maintenance therapy, was safe and tolerable in patients with advanced ovarian cancer, according to preliminary data from a small clinical trial presented at the 2018 Society of Gynecologic Oncology Annual Meeting. Read entire post (External website)

FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%

  FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and paediatric patients with B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More Information.

Earlier Pseudoprogression Seen in patients With Oligodendroglioma Treated With Proton…

2018-03-29 11:07:11 patients with oligodendroglioma developed pseudoprogression earlier after treatment with proton therapy compared with after photon therapy, according to the results of a retrospective trial comparing the rates of pseudoprogression that occurred in patients with anaplastic gliomas following treatment with different radiation therapy modalities. Source

PFS Improved in Frontline Squamous NSCLC with Atezolizumab Plus Chemo

2018-03-29 10:54:57 According to topline findings from the Phase 3 IMpower131 trial, the addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel delayed progression or death compared with chemotherapy alone for patients with advanced squamous non–small cell lung cancer. These results were released by Genentech, the manufacturer of the anti–PD-L1 agent. Source

Durable Responses to JCAR017 Observed in High-Risk DLBCL

2018-03-29 10:30:12 Responses to lisocabtagene maraleucel have been potent and durable in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma. Separate exploratory analyses of this population treated with liso-cel found that high tumor burden and a series of in ammatory biomarkers were associated with high chimeric antigen receptor T-cell expansion and higher rates […]

Trials Consider Role of Immunotherapy in Breast Cancer

2018-03-29 10:16:32 Mixed results have occured in recent trials testing immuotherapy in patients with breast cancer. Checkpoint inhibitors have been used as monotherapy in a pair of trials, reporting lackluster overall response rates. When immunotherapy was paired with chemotherapy, on the other hand, it usually revealed better results, and gave signals that immunotherapies combined with […]

FDA approved nilotinib for paediatric patients with newly diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI

  FDA approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CMLCP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. More Information.  March 22, 2018

FDA approved abemaciclib plus aromatase inhibitor for untreated postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer

  FDA approved abemaciclib (VERZENIO, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information.

FDA approved lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive GEP-NETs

  FDA approved lutetium Lu 177 dotatate (LUTATHERA, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analogue, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults. More Information.

FDA granted regular approval to olaparib in the treatment of (suspected) deleterious germline BRCA-mutated, HER2-negative MBC

  FDA granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. More Information  

FDA approved a broadened indication of afatinib in the 1st-line treatment of metastatic NSCLC with non-resistant EGFR mutations

  FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.  More Information.  

Discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Ph+ CML with a sustained molecular response

On 22 December, the FDA updated the product label for nilotinib (Tasigna®, Novartis) to include discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).

Nivolumab approved for melanoma with lymph node involvement or metastatic disease after resection

On 20 December 2017, the FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (Opdivo®, Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma with lymph node involvement or in patients with metastatic disease after complete resection. Nivolumab received prior FDA approval for the treatment of patients with unresectable or metastatic melanoma.