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A Look Back at FDA News in the Month of March

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018. Read full article (External website)

Denosumab Granted European Approval for Myeloma

Based on data from the Phase 3 482 trial, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. Read full article (External website)

HPV Vaccination Should Be Part of Oncology Cost-Reduction Strategy

The impact of staggering increases in the cost of individual antineoplastic agents for patients and the overall healthcare system cannot be overstated, and there appears to be no realistic solution to the current dilemma that is acceptable to the parties involved in this ongoing debate. Read full article (External website)

Lynch

Thomas J. Lynch, Jr, MD, brings an enthusiasm to exploring and developing treatments to help patients with cancer. Read full article (External website)

MRD Prognostic of Poorer Outcomes in AML

Molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia. Read full article (External website)

Thomas Gallo Named 2018-2019 ACCC President

The Association of Community Cancer Centers (ACCC) has named Thomas A. Gallo, MS, MDA, as the 2018-2019 president of ACCC. This was announced at the ACCC’s 44th Annual Meeting & Cancer Center Business Summit on March 16, 2018. Read full article (External website)

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 […]

Blinatumomab Granted FDA Approval for MRD+ ALL

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease. Read full article (External website)

Nilotinib Granted FDA Approval for Pediatric CML

Based on data from 2 clinical trials, nilotinib (Tasigna) has been approved by the FDA for the first- and 2nd-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. Read full article (External website)

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 […]

Combination of Atezolizumab and Cobimetinib Active in mCRC

The combinations of atezolizumab and cobimetinib induced a 31% disease control rate in patients with heavily-pretreated metastatic colorectal cancer. Results from a 2-stage phase Ib trial presented at the 2018 Gastrointestinal Cancers Symposium demonstrated an overall response rate of 8% (n = 7). All responses were partial responses. Read full article (External website)

Asian AYA Cancer Care Survey

This survey is organised by the ESMO/SIOPE Cancer in Adolescent and Young Adults (AYA) Working Group following successful mapping of the European AYA cancer care landscape. Read full article (External website)

Enzalutamide Granted FDA

Based on data from the Phase 3 PROSPER trial, a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer has been granted a priority review by the FDA, according to Pfizer and Astellas, the companies developing the antiandrogen agent. Read full article (External website)

T-VEC Injections Safe in patients with Advanced-Stage Liver Metastases

According to early results of an ongoing early-phase trial presented at the 2018 Society of Interventional Radiology Annual Scientific Meeting, image-guided injections of talimogene laherparepvec immunotherapy (T-VEC, Imylgic) were deemed tolerable in patients with advanced-stage liver metastases. Read full article (External website)

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)

How Can We Do Better at Preventing Cancer?

Language English February 22, 2018 lidia.schapira In this month’s From the Editor’s Desk, Dr. Schapira writes about prevention and what we can do to help understand and manage our personal cancer risk. Read full article (External website)

trial Finds Survival Benefit With Upfront Atezolizumab Combo for NSCLC

According to findings from the Phase 3 IMpower150 trial, significant improvement was found in overall survival with a treatment regimen of atezolizumab, bevacizumab, carboplatin, and paclitaxel compared to the combination of bevacizumab and chemotherapy alone for patients with advanced nonsquamous non–small cell lung cancer. Read full article (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.

Enfortumab Vedotin Granted FDA

Enfortumab vedotin has been granted a breakthrough therapy designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy. These findings have been released by Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate. Read full article (External website)

“Your Stories” Podcasts: How Cancer Impacts Families

Language English March 8, 2018 PATRA.WROTEN The Your Stories podcast series from ASCO’s Conquer Cancer Foundation provides insight into what it’s like to conquer cancer from different viewpoints. The podcasts featured here touch on the many ways that cancer can affect a family. Source

What You Need to Know About Colorectal Cancer

2018-03-13 21:00:00 Language English March 13, 2018 Jeffrey.Meyerhardt Being diagnosed with colorectal cancer can be scary and confusing. Dr. Jeffrey Meyerhardt, an expert in colorectal cancer, describes the 4 questions that any newly diagnosed patient should ask. Source

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

Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma

2018-03-29 10:42:10 Based on findings from the Phase 3 ECHELON-1 trial, brentuximab vedotin (Adcetris) has been approved by the FDA for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate. […]

Cancer Stories: How We Make Sense of Cancer

2018-03-22 21:00:00 Language English March 22, 2018 lidia.schapira In this month’s From the Editor’s Desk, Dr. Schapira writes about the power of storytelling in cancer care and how this led to the development of a podcast series with the Journal of Clinical Oncology. 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+ CML-CP) 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.