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ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised

This year’s American Society of Clinical Oncology (ASCO) annual meeting includes two Phase III studies in the second-line treatment of the disease. Moreover, data with several immune-checkpoint inhibitors were presented, including the KEYNOTE-224 with pembrolizumab. Welcome to the summary of the ASCO 2018 HCC track.

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.

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Olaparib Under Review by EMA for BRCA-mutated, HER2-negative Breast Cancer

A marketing authorization application for olaparib (Lynparza) for the treatment of women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the European Medicines Agency.

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EMA to Review Olaparib in BRCA-mutated, HER2-negative Breast Cancer

The European Medicines Agency has accepted a marketing authorization application for olaparib to treat women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.

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AKT Inhibitor May Overcome Chemotherapy Resistance in 2 Breast Cancer Subtypes

A novel inhibitor that targets the AKT node in the PI3K pathway may offer a treatment option in cases of resistance to chemotherapy in 2 patient populations: triple-negative breast cancer or estrogen receptor

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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.

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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 of standard and emerging treatments to achieve optimal outcomes.

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Expert Highlights Current Advancements and Questions in Breast Cancer Treatment

Kornelia Polyak, MD, PhD, discusses several exciting advancements in the field of breast cancer, including immunotherapy, PARP inhibitors, and liquid biopsies.

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Trastuzumab Regimen Extends PFS in Rare Endometrial Cancer

Adding trastuzumab to chemotherapy increased progression-free survival for patients with advanced HER2/neu-positive uterine serous carcinoma,

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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.

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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.

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Trastuzumab Biosimilar Receives Positive Opinion From CHMP for European Approval

A marketing authorization for ABP 980, a biosimilar to trastuzumab (Herceptin), has been issued a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

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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.

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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.

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Trastuzumab Deruxtecan Receives Expedited Review in Japan for Gastric Cancer

Japanese regulators have granted a Sakigake designation to trastuzumab deruxtecan (DS-8201), for the treatment of patients with HER2-positive gastric cancer that is refractory to trastuzumab (Herceptin).

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EMA Recommends Granting a Conditional Marketing Authorisation for Rucaparib

2018-03-27 03:31:00

It is recommended in previously treated platinum-sensitive, relapsed or progressive BRCA mutated high-grade epithelial ovarian cancer

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Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma

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.

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FDA Approves Nilotinib for Paediatric patients with Newly Diagnosed or Resistant/Intolerant Ph-Positive CML in Chronic Phase

2018-03-28 22:16:00

Approval is based on results in paediatric patients from CAMN107A2120 and CAMN107A2203 studies

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